B16171brochure PDF

BioProcess International
Conference & Exhibition
The most
innovative science
Conference: October 4-7, 2016

Exhibition: October 5-7, 2016
Boston Convention and Exhibition Center
Boston, MA
THE LARGEST BIOPROCESSING EVENT

BRINGING YOU THE SCIENCE, TECHNOLOGIES
AND PARTNERS NEEDED TO ACCELERATE
PROMISING BIOLOGICS TOWARDS
COMMERCIAL SUCCESS
The largest exhibition

devoted to biomanufacturing
The right partners for you
BPIevent.com
Event Partners
THE GLOBAL MEETING PLACE FOR BIOPROCESSING

SCIENCE, TECHNOLOGY AND NETWORKING
1,800+ 225+
TOP-LEVEL SPEAKERS
BIOPROCESSING
PROFESSIONALS
Improve integration, productivity and

cost savings in your current line of
work by hearing case studies and new
data from experts working across the
entire bioprocessing spectrum.
Achieve clinical and commercial success by

collaborating with leading pharma, biotechs,
academia and solution providers from across
the globe.
100+
160+
Stay at the forefront of bioprocess

innovation by accessing new data
from fellow attendees.
Accelerate your drug product to

market by accessing innovative
products and technologies in the
largest exhibit hall devoted to
biopharmaceutical manufacturing.
PEER-SUBMITTED
POSTERS
EXHIBITORS
"BPI was a great success and I absolutely enjoyed every

moment of it. I'm looking forward to next year."
Rahul Godawat, Senior Scientist, Genzyme Sanofi
"BPI was a great, great conference. I enjoyed the

presentations, discussions and networking."
"This conference is a great place to meet the

technical experts in the industry. I enjoyed
exchanging research ideas with global
companies and sparking new collaboration."
Saeko Tanaka, Bioprocess Engineer, Chugai Pharmaceutical Co., Ltd, Japan
Kelvin Lau, Senior Process Engineer, Abbott
For up-to-date program information and new abstracts, visit: www.BPIevent.com
6 CONTENT-DRIVEN TRACKS
MANUFACTURING STRATEGY
Reduce costs, increase yield and remain flexible in your biomanufacturing operations by applying best practices and disruptive
technologies used by manufacturing and facility experts from around the world.
ANALYTICAL, FORMULATION AND QUALITY
Stay abreast of analytical tools and formulation strategies to ensure your products meet increasing quality expectations and regulatory
standards by gaining guidance from industry thought leaders and regulators.
CELL CULTURE & UPSTREAM PROCESSING
Accelerating timelines for mAbs and novel modalities utilizing novel technologies, methodologies, and processing platforms while
controlling COGs and optimizing efficiency, productivity, and quality from early stage development to commercial scale manufacturing.
RECOVERY & PURIFICATION
Applying innovative technologies, platforms, and approaches to accelerate and streamline downstream process development to improve
COGs; operational capacity and efficiency; process characterization, control and quality of an ever expanding pipeline of novel molecules.
DRUG PRODUCT MANUFACTURING & FILL-FINISH PROCESSING
Accelerate your drug substance towards a finished drug product by integrating technologies and strategies to improve the interface
between drug substance development and drug product manufacturing/fill-finish processing.
EARLY STAGE BIOLOGICS AND COMPANIES
Learn how to successfully transition your biologic from discovery through clinical trials and beyond by hearing guidance from experts on
how to reduce risk, minimize costs, navigate funding milestones and decrease time to IND and later stage development.
MEDIA PARTNERS:
FierceBiotech
THE BIOTECH INDUSTRYS DAILY MONITOR
Register Early for Best Savings www.BPIevent.com 800-390-4078
AGENDA AT-A-GLANCE
Tuesday, October 4, 2016 Pre-Conference Symposia
9:00-5:00
Continuous Processing
Sponsored by: Pall Life Sciences
Supply Chain Security and Transparency

from Starting Materials to Patient
Cell-Based ImmunotherapiesFrom Concept to Commercialization
Program Management of
Biologics Development
7:30
Wednesday, October 5, 2016 Main Conference

Cell Culture &
Upstream Processing
7:55-9:30
Exhibit Hall Hours: 4:30 pm-6:30 pm

Drug Product Manufacturing
& Fill-Finish Processing
Recovery & Purification
Optimizing the Transition into Early Stage

Development
Innovation at the Interface of Upstream and

Downstream Processing
Integrated Continuous Processing

for Cell Culture
Sponsored by Pall Life Sciences
Future Technologies and Their Impact on

9:30-10:30
10:30-12:00
Manufacturing Strategy
Analytical, Formulation & Quality
Manufacturing Optimization and Process

Drug Product-Fill Finish Case Studies and
Intensification: Predictive Models and Product
Technical Challenges
Lifecycle Management
Welcome Breakfast Presentation Sponsored by: Pall Life Sciences
Drug Product-Fill Finish Technologies
New Paradigms in Manufacturing Facilities

and Technologies
Sponsored by: GE Healthcare
Analytical Testing Strategies

and Analytical Control
Improving Cell Line Development

with Novel Technologies
Drug Product Strategies for Preifilled

Syringes and Devices
Evolution in mAb Process Platforms
Best Practices for Leachables Testing and Microbial Monitoring
3:00-4:30
Keynote Presentations
4:30-6:30
Opening Night Celebration of Science Reception in the Exhibit Hall Co-Sponsored by: KNect 365, GE Healthcare & Lonza
6:45-9:30
Womens Executive Leadership Dinner
7:00-10:00
2016 BioProcess International Awards Gala Dinner and Ceremony
Thursday, October 6, 2016 Main Conference

Integration of Analytical Methodologies

and Technologies
Streamlining Transfers & Progression from

Bench to Bedside
Drug Product Strategies for Biologics
Cell Culture Acceleration

& Optimization
Platforms and Novel Approaches

for Biotherapeutics
Sponsored by Bio-Rad Laboratories
Primary Packaging Components and

Container Closure
Early Stage Biologics

& Companies
Harmonization of Manufacturing Strategies

Regarding Human Performance and Room
Classification/Gowning
Integration of Analytical Methodologies and

Technologies
Accelerating Development of
Early Stage Programs
Open Forum: CMC Dossiers

for Biotech Products
Quality Risk Assessment and

QC Testing Strategies
Funding Strategies for

Early Stage Companies
Keynote Presentation
12:35-1:05
Open Forum: Industry-Academia

Collaboration on Translation Research and
Biomanufacturing
Technology Workshops Sponsored by: Ajinomoto Co., Inc, Irvine Scientific, Vironova, Entegris, GE Healthcare
1:05-2:25
Networking Luncheon in the Exhibit Hall

Improving Process Understanding,
Control, and Productivity at Clinical and
Commercial Scale
Drug Product Case Studies:

Residual Moisture, ADCs and
Freeze Dryer Characterization
Novel Single-Use Applications

in Cell Culture
Sponsored by Sartorius Stedim Biotech
Streamlining Transfers & Progression from

Bench to Bedside
Manufacturing for Late Stage Development

and Commercial Products
Sponsored by Fujifilm Diosynth Biotechnologies
Networking Refreshment Break in the Exhibit Hall
4:00-5:00
5:00-6:00
Analytical, Formulation
& Quality
Technology Workshop with Light Continental Breakfast Sponsored by: Repligen
9:30 - 10:15
2:25-4:00
STAT Panel Discussion - President Clinton or President Trump: What Our Next President will Mean for Biotech and Pharma
Party In the Park
6:00-10:00
Friday, October 7, 2016 Main Conference
Exhibit Hall Hours: 9:15 am-2:30 pm
Cell Culture &

Upstream Processing
Development and Production

of New Modalities
Innovations in High-Throughput
Development & Process Modeling

Case Studies: Visual Particles, Process

Characterization and Scale-up
Flexible Designs and Considerations for New

and Aging Manufacturing Facilities
9:15-10:15
Plenary Keynote Speaker
12:35-1:05
Technology Workshops Sponsored by: GE Healthcare
1:05-2:25
Networking Luncheon & Last Chance for Poster Viewing in the Exhibit Hall
2:25-4:30
& Quality
Technology Workshop with Light Continental Breakfast Sponsored by: GE Healthcare
7:15-7:45
8:05-12:30
Two-Day Training Courses
Exhibit Hall Hours: 9:15 am-6:00 pm
Cell Culture &

Upstream Processing
7:30-8:00
11:00-12:30
Luncheon Presentations Sponsored by: MilliporeSigma, Roche, Sartorius Stedim Biotech
12:40-1:40
8:10-9:15
Analytical Strategies for

Complex Therapeutics
Technology Workshops Sponsored by: BIASeparations, DNA 2.0, MaxCyte, GE Healthcare
12:05-12:35
1:50-2:55
Modern CMC Regulatory Strategies
BPI BioBrew Networking Event @ Harpoon Brewery Sponsored by Kaneka & Pall Life Sciences (limited capacity; registration required)
Impact of Process Conditions

on Product Quality
Process Automation, Integration &

Intensification
Drug Product and Fill-Finish Strategies for

Cell Therapy Products
Strategies to Control Raw Material

Variability and to Improve Supply Chain
Transparency and Security Sponsored by:
Avantor Performance Materials
Formulation Strategies for Biologics
Analytical Strategies for Biosimilars and

Glycan Profiling
TWO-DAY TRAINING COURSES TUESDAY-WEDNESDAY, OCTOBER 4-5, 2016 9:00AM-5:00PM

CMC ANALYTICAL, COMPARABILITY AND STABILITY STUDIES
INTRODUCTION TO BIOPHARMACEUTICAL MANUFACTURING
(Room 206A)
(Room 206B)
This course provides a comprehensive overview of the phase-specific requirements for CMC analytical
characterization, comparability, release and stability of biotechnology products from the preclinical
phase through clinical trials to commercialization and post-approval. Analytical considerations for a
wide variety of biopharmaceuticals are discussed, including monoclonal antibodies, therapeutic proteins,
gene therapy, vaccines, and complex products (e.g. antibody drug conjugates). Details are presented
on establishing and maintaining product reference standards, designing successful comparability tests
(including specifics for biosimilar studies), setting meaningful product specifications, conducting forced
degradation studies, technology transfer and bridging changes in analytical methods and generating
effective stability protocols. Critical elements of laboratory quality practices that significantly impact the
reliability of test data from R&D through cGMP are illustrated.
This course provides a fundamental understanding of biopharmaceutical manufacturing.

Organized along the development path, the course will describe the activities necessary to bring a
biopharmaceutical from discovery to market. Included in the course will be the analytical, quality and
regulatory challenges as well as the technical activities required. The instructors will discuss how
development activities integrate and the best practices for drug substance and drug product production.
At the conclusion of the course the attendee will have learned the steps needed to develop and produce
a safe and effective biopharmaceutical that meets industry and patient needs. Identified during the
course will be how to implement QbD in development and communicating with regulatory agencies
throughout development.
Course Instructor:
Course Instructors:
Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants
Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC
Frank Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants
TUESDAY, OCTOBER 4, 2016 PRE-CONFERENCE SYMPOSIA 9:00am-5:00pm

8:00 Registration and Coffee
Cell-Based Immunotherapies
From Concept to Commercialization
On Time and within Budget: Successful Program Management of

Biologics Development Tools, Techniques and Lessons Learned
(Room 211)
Overview:
Overview:
Cell-based immunotherapies have the potential to transform current medical practice and offer
an opportunity to effectively manage what were once considered untreatable diseases. Despite a
large increase in basic science activity in the cell therapy arena, alongside a growing portfolio of cell
therapy trials, the number of industry products available for widespread clinical use correlates poorly
with such a magnitude of activity with the number of cell based therapeutics in mainstream use
remaining comparatively low. This course serves to incorporate key aspects of the commercialization
process and examines how therapeutic candidates can be successfully translated from basic
science into commercially viable products. The course will address fundamental translational
barriers spanning the so-called "valley of death" and delineate sustainable and efficient mechanisms
that can support the commercialization process. Topic coverage will include preclinical, clinical,
manufacturing, intellectual property, regulation and market components.
Topics to be Covered:
Instructor:
David A. Brindley, MEng, DPhil, FRI, FRSA, Chief Scientific Officer, Aegate; Managing Partner, IP
Asset Ventures; Senior Research Fellow, Paediatrics, University of Oxford, United Kingdom
(Room 212)
Strong Program Management is critical to the successful completion of biologics programs.

This workshop presents proven tools and methodologies while focusing on the idiosyncrasies
of biotechnology. We will review the integration and management of R&D, CMC, preclinical and
clinical programs from discovery to licensure/commercial launch. We will address partner and
supplier management (CMOs, CROs) as well as the securing and management of program funding
(government and private equity).
Biologics Program Management
Shrinking development timelines
Cross functional integration
Working within smaller budgets
Becoming more virtual through partnering and subcontracting
Integrating biotechnology activities and organizations
CMO management
CRO management
Securing dilutive and non-dilutive funding
Speakers:
Peter Latham, President and Managing Partner, Latham BioPharm Group, Inc., PgMP
Joshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMP
Gretchen Stup, Senior Consultant, Latham BioPharm Group, Inc., PMP
BPI
"BIOBREW"
EVENT
UNIQURE
SITE TOUR
REPLIGEN
OPUS FACILITY
TOUR
6
Tuesday, October 4 7:30pm-10:30pm
Catch the shuttle outside the BCEC for the

BPI BioBrew Networking Event @ Harpoon Brewery
Sponsored by
Limited capacity; registration required. Buses depart from 7:00pm at the BCEC Shuttle bus stop, please follow signs
from the KNect365 registration area.
Tuesday, October 4 1:00pm
Sartorius will be hosting a Site Tour to the UniQure Facility in Lexington, MA
Please meet at the BWB shuttle bus stop - follow the signs from the KNect365 registration area.
Buses will return at 6:00pm. Pre-registration required.
Tuesday, October 4 1:00pm
Repligen will be hosting a site tour to it's OPUS facility in Waltham, MA

Please meet at the BWB shuttle bus stop - follow the signs from the KNect365
registration area. Buses will return at 4:30pm . Pre-registration required.
and

Sponsored by
(Room 208)
9:00 Chairperson's Opening Remarks
Marc Bisschops, Ph.D., Technology Director, Continuous Processing, Pall Life Sciences, Holland
GMP Implementaton of Continuous Bioprocessing

9:15 Continuous Bioprocessing with Sophisticated Integrated Automation
Strategies at Scale
Mark A. Brower, Ph.D., Associate Principal Scientist, Merck & Co., Inc.
1:15 Chairperson's Remarks

Peter Levison, Technology Development Director, Pall Life Sciences
Case Studies on Unit Operations and Integrated Continuous Processing

1:30 Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities
Fernando Garcia, Process Engineer, Just Biotherapeutics, Inc.
2:00 Combining Novel Technologies to Improve Cell Separation and Impurity Removal
Laura Dinn, M.Eng., Bioprocess Engineer, Merrimack Pharmaceuticals
9:45 Process Chromatography Platform for the Operation of Continuous Bioprocessing

Mark Schofield, Ph.D., Principal R&D Engineer, Pall Life Sciences
2:30 Continuous Concentration and Diafiltration

Regeneron
10:15 Networking Refreshment Break in Foyer
3:00 An Alternative Cell Clarification Technology: Optimization, Applications and Scale-Up

John Armando, M.S., Engineer II, Process Biochemistry, Biogen
Regulatory and Quality Considerations

10:45 Applying ICH Q8/Q9 to Continuous Processing
Relevance of QbD/QRM
PAT needs/gaps
Process Integration and Control
Regulatory challenges
Mitigation
Marc Bisschops, Ph.D., Technology Director, Continuous Processing, Pall Life Sciences,
The Netherlands
11:15 Interactive Panel Discussion - Can the Adoption of Continuous Bioprocessing
Technologies in Critical Applications be Accelerated?

Which are the Regulatory Points that Concern Customers?
3:30 Networking Refreshment Break in Foyer
Making the Business Case for Continuous Processing

4:00 Why CMO Means ""Continuous Manufacturing Organization""
Michelle Najera, Ph.D., Scientist, Downstream Development, CMC Biologics
4:30 Informing the Business Decision - New Models for Continuous Bioprocessing
Tom Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc.
5:00 Chairperson's Closing Remarks
Moderator: Peter Levison, Technology Development Director, Pall Life Sciences
12:00 Networking Luncheon

Supply Chain Security and Transparency

from Starting Materials to Patient
Modern CMC Regulatory Strategies

and Insights - from Concept to Approval
(Room 213)
(Room 209)
Symposium Moderator and Opening Remarks
Overview:
On average, it still takes in excess of 10 years to develop a new biopharmaceutical drug product. It is
estimated that the cost of developing a new biopharmaceutical drug product, and taking into account
the > 90% failure rate, is over $2 billion. Conscious of this, the modern viewpoint is looking at ways in
which to reduce this overall time and cost element. One strategy is to impart an approach of accelerated
development which, if done sensibly, can present an attractive and viable option. Quality focused planning,
e.g. facilitated by quality by design, can also be used to potentially shave off time to approval, whilst
maintaining all important quality and regulatory maneuverability. Although faster development is attractive,
regulatory aspects, particularly regulatory CMC also needs to keep up pace - which presents a number of
difficult challenges. Pinch points:
S
ometimes it may become necessary to challenge the norm and push back on certain regulations,
within valid reason.
F
DA Breakthrough Therapy designation and EMA Priority Medicines (PRIME) designation provide an
automatic ticket to enter the fast lane - so welcome to the reality!
A
bove all it is still important to have a well authored and watertight regulatory dossier by which the
competent authority will review the drug product in order to issue final marketing approval.
This session provides an overview of modern regulatory CMC strategies which may be selectively applied
for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal
products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the
overall time and cost. This interactive session will focus on biopharmaceuticals, biologics, ATMPs,
vaccines and biosimilars. Collective team discussions, whiteboard exemplification and work-throughs will
be made on key topic points.
Topics to be Covered:
U
nderstanding of the nature of the challenge: from concept to authorization
M
odern mindsets: Technically driven approaches: accelerated development pros and cons
B
e ready to fast-track- Breakthrough Therapy designation & Priority Medicines (PRIME);
accelerated approval; rolling submissions
9:00 Introduction to Rx-360 and our Patient-Centric Work

Mark Paxton, CEO, Rx-360 International Pharmaceutical
Supply Chain Consortium
Morning Session: Why Upstream Quality Matters

9:15 Benchmarking of Industry Best Demonstrated Practices to Mitigate Risk and
Enhance Transparency
Rob Welsh, Vice President, Bioprocessing Segment Solutions, VWR and Rx-360 International
Pharmaceutical Supply Chain; Consortium Board Member & Co-Chair of Supply Chain Security
Steering Committee
10:00 Best Practice for Improving Quality Agreement Experience between You and
Your Vendor
Rick Calabrese, Global Director of Corporate Quality Systems, Sartorius Stedim North America
10:45 Short Refreshment Break

11:00 Temperature-sensitive Air Freight How Utilizing Data Can Mitigate Risk
Frank Cascante, Head of Business Development Americas, DHL Temperature Management
Solutions, LifeconEx
11:45 Overview of the Rx-360 Joint Audit Program
Mark Paxton, CEO, Rx-360 International Pharmaceutical Supply Chain Consortium
12:15 Luncheon
Afternoon Session: Who are Your Trading Partners and Why

1:15 Comprehensive Supply Chain Security Management System
Reggie Jackson, Senior Manager Supply Chain Security, Pfizer
E
xploration of the lifecycle of the investigational and final dossier:
2:00 Protecting Patients with Serialization: Key Building Blocks

Duke Danont, Director, Supply Chain, Amgen, Inc.
B
reakdown of Timelines: Important Milestones
2:45 Short Refreshment Break
H
igh level dissection of CTD module 3: IND/IMPD BLA/MAA - essential content and structuring
T
he bridge between US and EU - important considerations
3:00 Compliance with Good Distribution Practices: How Many standards?

David Ulrich, QA Director Supply Chain, Abbvie
N
avigation of the essential guidelines and building blocks: biopharmaceuticals, biologics, ATMPs,
vaccines, biosimilars; objective strategies of each
3:45 Partnering with Suppliers for Improvements; A Supplier Collaboration
U
sing Quality by Design to your best advantage
Program Perspective
Jay Patel, Genentech
R
est of World (RoW) CMC / regulatory considerations.
4:30 Close of Session
C
ase Study of common issues: regulatory CMC
Speaker:
Richard Dennett, Ph.D., Director, Voisin Consulting Life Sciences
Schedule Subject to Change
WEDNESDAY, OCTOBER 5, 2016

Cell Culture & Upstream Processing
(Room 208)
7:00
7:55
Chairpersons Remarks
Optimizing the Transition into

Early Stage Development
FEATURED PRESENTATION:
Comprehensive Study of Different Harvest

Technologies Under Several Biological Systems
Lyophilization Cycle Tech Transfer Strategies to

Ensure Success
Application of Process Optimization in

Preclinical Manufacturability to Achieve
Stable High Level Expression of Protein Therapeutics
Comparison of Clarification Technologies for Viral Vectorbased Vaccines
Drug Product Manufacturing Challenges Due to Dissolved

Gas in Drug Substance & Mitigation
Acoustic Wave Separation A Scalable Disruptive Technology

for Continuous Clarification of Fed Batch and Perfusion Cell
Culture Prior to Capture Chromatography
Hi-Intensity Upstream Processes enabling an Integrated

Continuous Bioprocess
Matthew Gagnon, B.Eng, Senior Scientist, BioProcess Research &

Development, Pfizer, Inc.
End-to-End Integrated Continuous BioProcessing

Platform for Biologics Manufacturing
Engin Ayturk, Ph.D., R&D Manager, BioPharm Applications R&D,

Pall Corporation
12:05
12:40
Juan Lagos, Senior Scientist, Upstream Process Development,

Patheon Biologics
Paul Ko, Ph.D., Senior Scientist, API Large Molecule,

Cell Technologies, Janssen R&D
Welcome Breakfast Presentation Sponsored by:
Sponsored by:
Chairperson: Marc Bisschops, Ph.D., Technology Director,
Continuous Processing, Pall Life Sciences, The Netherlands
11:30
Drug Product-Fill Finish Case Studies and

Technical Challenges
Early Risk and Developability Assessment Approaches

Sheri Nidositko, Ph.D., Fellow/Lab Head, Cell Line
Integrated Continuous Processing

for Cell Culture
11:00
Sponsored by
Kevin Maloney, Ph.D., Director, Technical Development, Biogen
Weiqiang Cheng, Ph.D., Senior Scientist, Drug & Combination

Product Development, Shire
Lynette Buck, Senior Associate Scientist, Drug Substance PD,

Amgen Inc.
10:30
Innovation at the Interface of Upstream

and Downstream Processing
Peter Gagnon, Vice President, Peregrine Pharmaceuticals Inc.
Development and Protein Production, Integrated

Biologics Profiling, Novartis
9:30
Amitava Kundu, Associate Director, Technical Operations,

Takeda Pharmaceutical
Challenges from Drug Substance to Drug Product, A Case

Study on Resolving Solubility and Stability Issues of a
Tough Protein Molecule
Martin J. Allen, Ph.D., Senior Director, BioProcess Research &

Development, Pfizer
9:00
Across the Great Divide: The Upstream Origins

and Downstream Ramifications of a Newly
Discovered Contaminant Class
Optimizing Transition Points for Multiple Modalities Thinking Beyond mAbs

8:30
Drug Product Manufacturing &

Fill-Finish Processing (Room 211)
(Room 209)
Registration and Coffee (210 Foyer)

Susan Dana Jones, Ph.D., Vice President and Principal Consultant,
BioProcess Technology Consultants
8:00
Dan Dixon, Senior Manager, Technical Services, BioTherapeutics

Pharmaceutical Sciences, Pfizer, Inc.
Suresh Choudhary, Associate Scientist, Formulation Sciences,

MedImmune LLC
(Room 210ABC) (See right hand panel)
Future Technologies and Their Impact on

Sponsored by
Drug Product-Fill Finish Technologies
Chairperson: Andrew Tustian, Director Process Development and

Pre-clinical Manufacturing, Regeneron
Single-Use Primary Capture Technology with the

Promise to Deliver New Standards for the
Economics, Convenience and Reliability of mAb Bioprocessing
INTACT Filling: A Safer Drug Product Filling Technology in

a CNC environment
Process Development for the EnzymeMediated Manufacture of a Site-Specific

ADC for Early Clinical Trials
Stability Test Work to Show Vaccine Compatibility with

Aseptic Blow/Fill/Seal Technology
Hybrid Filters: An alternative to Chromatography?
Controlled Nucleation for Lyophilization Ensuring

Robustness of Nucleation through a Mechanistic
Understanding of the Technology
Oliver Hardick, Ph.D., CEO, Puridify Ltd., United Kingdom
Birte Nolting, Ph.D., Senior Principal Scientist, Biotherapeutics

Research and Development, Conjugation and Polytides Process
Development, Pfizer
Abhiram Arunkumar, Ph.D., Scientist I, Biologics Process
Development, Bristol-Myers Squibb Company
Technology Workshops (See right hand panel)

Luncheon Presentations (See right hand panel)
David Miller, Manager, Device Performance Engineering, MedInstill

Development LLC
Timothy Kram, General Manager, Rommelag Engineering

Otto Schubert, Ph.D., General Manager, Rommelag CMO
Jacob Luoma, Engineer 1, Pharmaceutical Processing and

Technology Development, Genentech, A Member of the Roche Group
WEDNESDAY, OCTOBER 5, 2016

Analytical, Formulation and Quality
(Room 212)
Registration and Coffee (210 Foyer)
7:00
7:55
(Room 213)
Ming Lei, Senior Research Associate, Protein Analytical Chemistry, Genentech
Bill Whitford, Strategic Solutions Leader, BioProcess,

GE Healthcare Life Sciences
Manufacturing Optimization and Process

Intensification: Predictive Models and Product
Lifecycle Management
8:00
DOE and Predictive Modeling to Improve Decisions on the

Manufacturing Floor
9:00
12:40
HPLC Fingerprinting Approach for

Increased Speed and Flexibility of PAT
Sebastijan Peljhan, Ph.D., BIA Separations
(Room 104C)
A Systematic Approach to Engineering
Antibody Expression
Maximizing the Value of Commercial Scale Data:

A Case Study
Analytical Characterization of ADCs Conjugated

Through Lysines
(Room 102B)
Welcome Breakfast Presentation Sponsored by:

Sponsored by:
Hongling Han, Ph.D., Principal Scientist, Integrated Biologics

Profiling, Novartis
(Room 210ABC) (See right hand panel)
Analytical Testing Strategies and

Analytical Control
Development of a UHPLC Peptide Map for a Commercial
Control System and Its Application to Crosslink Identification
A Global Technology Roadmap for Biopharmaceutical

Manufacturing: An Update from BPOG
Innovative Methods in Quantitating Host Residual DNA in

Biologic Drugs
Footprinting our Drugs: Biologics Process Mass

Intensity Tool
Avid Bioservices, Inc.
Strategies for Optimized Cell Culture Medium Design

Kalle Johnson, Development Team Manager, GE Healthcare
(Room 104A)
Accelerating Biotherapeutic
Development using Scalable CHO
Cell Transfection
Joan Hilly Foster, Senior Field Application Scientist, MaxCyte, Inc.
(Room 103)
Practical Considerations for Bioproduction Expansion

into China
Bonnie Shum, Engineer, Global Biologics Manufacturing Sciences

and Technology, Genentech, Inc., A Member of the Roche Group
12:05
Workshops
Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and

Pharmaceutical Sciences, ImmunoGen, Inc.
Bert Frohlich, Ph.D., Director, Strategy and Technology Lifecycle,

Manufacturing Sciences & Technology, Shire
Thomas Ryll, Ph.D., Vice President, Process and Analytical
Development, Immunogen
11:30
12:05 Technology
Suresh Nulu, Senior Engineer II, Parenteral Process Development, Biogen
Matt Roberge, Senior Director of Emerging Markets, Global

Technical Services, Pfizer
11:00
Michael Egholm, VP and General Manager, Pall Pharmaceuticals
(Room 104B)
Use of Slope Measurement for Increased Throughput of
IgG Purification: Better, Faster, Cheaper.
Concentration Determination of Antibody-drug Conjugates (ADCs) Pete Gagnon, Vice President, Process Sciences,
The Use of Predictive Models to Transform

Drug Product Development Paradigms
A Case Study on Drug Product Mixing
New Paradigms in Manufacturing

Facilities and Technologies
10:30
Pall Biopharmaceuticals' Leader Provides

an Update on Significant Technology
Advances Enabling Integrated Continuous BioProcessing
Kate Caves, MSc., Principle Scientist and

Director of Business Development, DNA2.0
Tom Mistretta, Principal Engineer, Process Development, Amgen, Inc.

9:30
Analytical Assay Design and Automation for CAR

T-cell Therapy
Breakfast Presentation (Room 210ABC)
Junxia Wang, M.D., Ph.D., Fellow, TRD Process Analytical Design,

Cell and Gene Therapies Unit, Novartis
Martin Kane, Managing Data Scientist, Exponent
8:30
Analytical Strategies for Complex Therapeutics
9:30 Welcome
Ming Lei, Senior Research Associate, Protein Analytical Chemistry,

Genentech
Musaddeq Hussain, Ph.D., Principal Scientist, BioProcess

Development, Merck Research Laboratories
12:40 Luncheon
Presentations
Fast Track to Your Qbd Approach

Integrated Bioreactor, Sensor an
Software Platform to Accelerate Antibody Development
Dr. Christel Fenge, VP Marketing and Product Management
Fermentation Technologies, Sartorius Stedim Biotech GmbH
(Room 205A)
Go Beyond: How the Biopharma Risk

Equation is Changing and Strategies
to Manage for the Future
Andrew Bulpin, Ph.D., Executive Vice President,
Head of Process Solutions, MilliporeSigma
(Room 205B)
PANEL: Sample Automation on Cedex Bio HT

An Automated High Throughput AlphaLISA Assay for Host
with SEG-FLOW
Cell Protein Quantitation in Early Stage Screening
Panelists:
Zhichao Fang, Ph.D., Scientist, Process Development,
Bristol-Myers Squibb

Luncheon Presentations (See right hand panel)
Kristin ONeill, Associate Principal Scientist, Merck

Ankit Mehta, Scientist, Merck
Paul Strand, Application Engineer, Flownamics Steve Grimme, Field
Application Consultant, Roche Diagnostics
(Room 205C)
10
WEDNESDAY, OCTOBER 5, 2016 (CONTINUED)

Cell Culture & Upstream Processing
(Room 208)
1:50 Chairpersons Remarks

iMichael Butler, Chief Scientific Officer, National Institute of
Bioprocessing Research & Training (NIBRT), Ireland
Improving Cell Line Development with

Novel Technologies
1:55 Novel Technologies to Characterize
Clone Productivity
Tanner Nevill, Ph.D., Director, Product Applications, Biopharma,

Berkeley Lights, Inc.
2:25 Application of Gene Editing Technologies for Development
of Cell Lines - Enhancements to the CHOZN Expression

Platform: Faster and Safer Expression of Biologics
Through Cell Line Engineering
Scott M. Bahr, MSc., Senior Scientist, Cell Line Development and

Engineering: CHOZN Program, MilliporeSigma

(Room 209)
Nripen Singh, Ph.D., Senior Scientist, Biologics Development

Organization (BDO), Bristol Myers Squibb

Sponsored by
Kevin Maloney, Ph.D., Director, Technical Development, Biogen
Drug Product Strategies for Pre-filled Syringes

and Devices
Development of an Acidic/Neutral Antibody

Flow-Through Polishing Step Using Salt-Tolerant
Anion-Exchange Chromatography
Integrating Drug & Device Development for Best-in-class

Patient Treatment Experience
Platform for Downstream Innovations to Enable

Natraj Ram, Ph.D., Associate Director, Purification,
Component Selection Strategies for PFS- Risk Mitigation,

Performance, and Injection Volume Driving Innovative
Solutions
Rajesh Ambat, M.S., Principal Associate, Process Development Downstream, Eli Lilly
Manufacturing Sciences, AbbVie Inc.
Didier Pertuy, Vice President, Global Head Drug-Device Integrated

Development, Sanofi, France
Andrea Straka, Supervisor, Project Management,

West Pharmaceutical Services
Keynote Presentations (Room 210ABC)

3:00 Chairpersons Remarks Gnter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, R&D, GE Healthcare Life Sciences
3:10
Engineering Aspects and Practical Experience from Amgens Singapore Next Generation Manufacturing Facility
This presentation will discuss our experiences with the design and operation of Amgens Next Generation Manufacturing facility in Singapore.
An emphasis on engineering aspects and lessons learned from operating the plant will be presented.
Matthew Shields, Executive Director and Plant Manager, Amgen Singapore Manufacturing, Singapore
3:50
The Success and Future of ADCs

ADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the elements in their design, from target selection, selection of
the antibody, the cytotoxic payload, and the linker, are important. These elements will be illustrated with examples from ImmunoGens clinical pipeline, and with examples from the newest
developments in payload-linker chemistry in preclinical research.
John M. Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, Inc.
4:30
6:45
Opening Night Celebration of Science Reception in the Exhibit Hall co-sponsored by
and
and
Womens Executive Leadership Dinner (Room 253AB)
KEYNOTE PRESENTATION: Creating a Collaborative & Diverse Workforce: A Challenge for Life Sciences
Susan Windham-Bannister, President and CEO, Biomedical Growth Strategies LLC and Managing Partner, Biomedical Innovation Advisors LLC;
Immediate Past President and CEO, Massachusetts Life Sciences Center
Panelists: Toni Hoover, Ph.D., Director, Strategy, Planning, and Management for Global Health, Bill & Melinda Gates Foundation
Kristi M. Sarno, Senior Consultant, Latham BioPharm Group and National President, Women In Bio
Trudie Lang, Professor, Global Health Research Director, University of Oxford, UK
Rachel Morgan, Global Head Clinical Sciences and Innovations, Novartis Institutes for BioMedical Research
7:00
11
2016 BioProcess International Awards Gala Dinner and Ceremony (Room 210ABC)
WEDNESDAY, OCTOBER 5, 2016 (CONTINUED)

(Room 212)
(Room 212)
1:50 Chairpersons Remarks

Miriam Monge, Director of Process Development & Bioprocess & Bioprocess Platform Marketing Team, Integrated Solutions,
Sartorius Stedim FMT S.A.S, France
Best Practices for Leachables Testing and Microbial Monitoring

1:55 BPOG Leachables Best Practice Testing Guide for Industry
Ping Wang, Ph.D., Principal Scientist, Materials Sciences, Pharmaceutical Development and Manufacturing Sciences,
Janssen Research & Development
Seamus O'Connor, Associate Manager, Analytical Sciences, Regeneron Pharmaceuticals, Inc.
2:25 Microbial Monitoring for Biological Drug Substance - An Industry Perspective
Brian L. Bell, Ph.D., Manager, Process Microbiology, Process Lifecycle Management, Manufacturing Science & Technology, Bristol-Myers Squibb
CELEBRATION OF SCIENCE
Reception In The Exhibit Hall
Keynote Presentations (Room 210ABC)

3:00 Chairpersons Remarks Gnter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, R&D, GE Healthcare Life Sciences
3:10
Engineering Aspects and Practical Experience from Amgens Singapore Next Generation Manufacturing Facility
This presentation will discuss our experiences with the design and operation of Amgens Next Generation Manufacturing facility
in Singapore. An emphasis on engineering aspects and lessons learned from operating the plant will be presented.
Matthew Shields, Executive Director and Plant Manager, Amgen Singapore Manufacturing, Singapore
3:50
The Success and Future of ADCs
ADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the
elements in their design, from target selection, selection of the antibody, the cytotoxic payload, and the linker, are important.
These elements will be illustrated with examples from ImmunoGens clinical pipeline, and with examples from the newest
developments in payload-linker chemistry in preclinical research.
John M. Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, Inc.
4:30
6:45
Opening Night Celebration of Science Reception in the Exhibit Hall co-sponsored by
OPENING NIGHT
and
and
Womens Executive Leadership Dinner (Room 253AB)
KEYNOTE PRESENTATION: Creating a Collaborative & Diverse Workforce: A Challenge for Life Sciences
Wednesday, October 5 4:30 pm - 6:30 pm

Kick off your conference experience at the Opening Night
Party to celebrate the launch of Biotech Week Boston!
Explore our Celebration of Science theme with a taste
of molecular gastronomy from Bostons celebrity chefs.
The party will feature Dueling DJs, from the theater zone
while you catch up with colleagues and friends, network
with attendees, exhibitors and sponsors. Participate in
several interactive activities and/or relax in one of the
themed lounge areas. Enjoy a fun evening with food, drinks
and entertainment.
Co-Sponsored by
and
and
Susan Windham-Bannister, President and CEO, Biomedical Growth Strategies LLC and Managing Partner, Biomedical Innovation Advisors LLC;
Immediate Past President and CEO, Massachusetts Life Sciences Center
Panelists: Toni Hoover, Ph.D., Director, Strategy, Planning, and Management for Global Health, Bill & Melinda Gates Foundation
Kristi M. Sarno, Senior Consultant, Latham BioPharm Group and National President, Women In Bio
Trudie Lang, Professor, Global Health Research Director, University of Oxford, UK
Rachel Morgan, Global Head Clinical Sciences and Innovations, Novartis Institutes for BioMedical Research
7:00
2016 BioProcess International Awards Gala Dinner and Ceremony (Room 210ABC)
12
THURSDAY, OCTOBER 6, 2016

Cell Culture
(Room 208)

(Room 209)
7:30
Remarks
Nadine Ritter, Ph.D., President and Analytical

Advisor, Global Biotech Experts, LLC
Integration of Analytical
Methodologies and Technologies
8:15 (8:05) The
Use of a Novel Single

Cell Dielectrophoretic (DEP)
Cytometer to Monitor Changes in CHO
Cell Metabolism
Michael Butler, Chief Scientific Officer, National

Institute of Bioprocessing Research & Training
(NIBRT), Ireland
(8:30) Automating Cell Culture Procedures

Using Bio-capacitance
Chairperson's Remarks
Mark A. Snyder, Ph.D., Manager, Applications R&D

Group, Bio-Rad Laboratories
Streamlining Transfers &

Progression from Bench to Bedside
Optimizing the Simultaneous
Transfer of Two Drug Substance
Production Processes to a Start-up
Contract Manufacturing Organization
Adam Myrold, MSc., Engineer II, Global
Manufacturing Science and Technology,
Genentech, Inc.
Juhi Fernandes, Engineer I, Technical

Development, Biogen
Manufacturing gp120 Based

Novel HIV Vaccine Candidates:
(8:55) Experiences Automating the Roche
Simultaneously Meeting Demands of
Cedex BioHT and HiRes with the Flownamics
Cost and Rapid Progression from Bench
SegFlow On-line Sampling System
to Bedside
Devon Roshan Eisner, Engineer, Pharmaceutical

Processing and Technology Development,
Genentech, a Member of the Roche Group
Drug Product Strategies

for Biologics
Biologics Drug Product
Technology Transfer
Arun Jangda, Lead - Drug Product External
Manufacture, Drug & Combination Product
Development, Shire
INTACT Formulation for Better and Safer

Product
Andreas Toba, Ph.D., Director, Product Technology
and Performance, MedInstill Development LLC
Abhinav Shukla, Ph.D., Vice President,

Development and Manufacturing, KBI Biopharma
Keynote Presentation (Theater Zone, Exhibit Hall A)

9:30
Harnessing Science, Technology and Innovation to Improve Global Health

Toni Hoover, Ph.D., Director, Strategy, Planning, and Management for Global Health, Bill & Melinda Gates Foundation
13
(Room 212)
Technology Workshop with Light Continental Breakfast (Room 206B) (See right hand panel)
8:10 (8:00) Chairperson's
10:15
Registration and Coffee
7:00
8:45

Networking Refreshment Break in Exhibit Hall (Exhibit Hall A)
Kamal Rashid, Ph.D., Director, Biomanufacturing

Education & Training Center and Research
Professor of Biology/Biotechnology,
Worcester Polytechnic Institute
Harmonization of Manufacturing
Strategies Regarding Human
Performance and Room
Classification/Gowning
Changing the Performance Paradigm
in BioPharma: Integrating Human
Performance in Global Operations
Amy Wilson, Ph.D., Director, Performance
Development,Global Biologics Manufacturing &
Technical Operations, Biogen
Ewald Amherd, Head Quality Customer
Engagement, Lonza, Switzerland
Harmonization of Room Classification

and Gowning Requirements across the
Biopharmaceutical Manufacturing Industry
Lars Hovmand-Lyster, M.D., Principal Scientist
Recovery, Diabetes Active Pharmaceutical
Ingredients, Novo Nordisk, Denmark
THURSDAY, OCTOBER 6, 2016

and Quality (Room 208)
7:00
Registration and Coffee
7:30
Technology Workshop with Light Continental Breakfast t (Room 206B) (See right hand panel)
8:10 (8:00) Chairperson's
Remarks

Integration of Analytical
Methodologies and Technologies
8:15 (8:05) The
Use of a Novel Single

Cell Dielectrophoretic (DEP)
Cytometer to Monitor Changes in CHO
Cell Metabolism
Michael Butler, Chief Scientific Officer, National

Institute of Bioprocessing Research & Training
(NIBRT), Ireland
7:30 Technology

and Companies (Room 207)
Susan Dana Jones, Ph.D., Vice President and

Principal Consultant, BioProcess Technology
Consultants
Workshop with Light Continental Breakfast
Single-use XCell ATF Systems for Continuous Processing: 100% Cell Retention,
8x Faster Set-up, No autoclave
Christine Gebski, Vice President, Product Management and Field Application, Repligen
(Room 206B)
Improving Development Outcomes by
Aligning Developability Assessment
with Optimization
Robert Mabry, Ph.D., Senior Director of Protein
Sciences and Antibody Technology, Jounce
Therapeutics
(8:30) Automating Cell Culture Procedures

Using Bio-capacitance
8:45
Juhi Fernandes, Engineer I, Technical

Development, Biogen
(8:55) Experiences Automating the Roche
How Quick is Quick? How to Manage Risk

with Speed to Clinic
Susan Dexter, Senior Principal Consultant,
Cedex BioHT and HiRes with the Flownamics Latham BioPharm Group
SegFlow On-line Sampling System

Keynote Presentation (Theater Zone, Exhibit Hall A)

9:30
Harnessing Science, Technology and Innovation to Improve

Global Health
Toni Hoover, Ph.D., Director, Strategy, Planning, and Management
for Global Health, Bill & Melinda Gates Foundation
10:15
Networking Refreshment Break in Exhibit Hall (Exhibit Hall A)
14
THURSDAY, OCTOBER 6, 2016 (CONTINUED)

Cell Culture
Cell Culture Acceleration

& Optimization
Platforms and Novel Approaches

for Biotherapeutics
(Room 208)
Chairperson:
Sigma S. Mostafa, Ph.D., Vice President, Process
Development, KBI Biopharma Inc.
11:00
(Room 209)
Sponsored by:
Frozen Inoculum Approaches to

Debottleneck Facility Capacity
Development of a Custom Resin for

Purification of Fully Human
Shahid Rameez, Ph.D., Principal Scientist, Process Bispecific Antibodies and
Development, KBI Biopharma Inc.
Implications for Continuous Processing
Andrew Tustian, Eng.D., Associate Director,

Preclinical Manufacturing and Process
Development, Regeneron Pharmaceuticals, Inc.
11:30
Application of HIPDOG in
AMBR System
Paetrice Jones, M.S., Scientist, Pfizer
12:00
Accelerated CHO-Cell Culture

Perfusion Processes Using
Novel Frozen Seed Bag (FSB)
Nikhil Ramsubramaniam, Ph.D., Senior Scientist,

Upstream Processing, Bioprocess Technology &
Expression, Merck & Co.

Primary Packaging Components
and Container Closure
Hydrogen Peroxide Uptake in Primary
Packaging Components
Devon Roshan Eisner, Engineer, Pharmaceutical

Processing and Technology Development,
Genentech, a Member of the Roche Group
Case Study: Data on Liquid Shipping

in Single-use Bags Supporting
Biotech Process Qualification
Downstream Processing of a
Large Live Virus: Challenges in
Development and Scale up for
a Sterile Purification Process
PANEL DISCUSSION:
Adam Kristopeit, Associate Principal Scientist,

Vaccine Process Development, Merck & Co.
Elisabeth Vachette, Senior Global Product

Manager, Marketing, Sartorius Stedim FMT S.A.S.,
France
Challenges of Fill-Finish for Non-Standard

and Emerging Modalities
Moderator:
Peter Latham, President and Managing Partner,
Latham BioPharm Group, Inc.
Panelists:
Brian J. Hawkins, Ph.D., Senior Application
Scientist, BioLife Solutions
Thomas Page, Ph.D., Vice President, Engineering,
Fujifilm Diosynth Biotechnologies Texas
Hari Pujar, Ph.D., Vice President, Technology
Development & Manufacturing, Moderna
Therapeutics
Mark Yang, Ph.D., Director of Fill Finish
Development, Sanofi Genzyme
12:35
1:05
15
(Room 212)
Open Forum: Industry-Academia

Collaboration in Translational
Research and Biomanufacturing of
Next-Generation Biologics
Moderator:
Kamal Rashid, Ph.D., Director, Biomanufacturing
Education & Training Center and Research
Professor of Biology/Biotechnology, Worcester
Polytechnic Institute
Panelists:
An Efficient Two-Column
Platform for Recombinant
Bacterial Antigen Production
Xuemei He, Ph.D., R&D Manager, Chromatography

Media Chemistry, Bio-Rad Laboratories
Mark S. Klempner, M.D., Executive Vice Chancellor,

Mass Biologics and Professor of Medicine,
University of Massachusetts Medical School
Sridaran Natesan Ph.D., Vice President, Strategic
Initiatives & Science Relations (North America),
Sanofi
Susan Roberts, Ph.D., Professor and Head,
Chemical Engineering Department, Worcester
Polytechnic Institute
Stacy Springs, Ph.D., Director, Biomanufacturing
Program, Executive Director, Consortium
on Adventitious Agent Contamination in
Biomanufacturing, MIT Center for Biomedical
Innovation
Jerome Ritz, M.D., Executive Director, Connell
OReilly Manipulation Core Facility and Professor of
Medicine, Dana-Farber Cancer Institute, Brigham
and Womens Hospital, Harvard Medical School
David Dismuke, Ph.D., Director of Vector
Production, Voyager Therapeutics Inc.

and Quality (Room 213)

and Companies (Room 207)
Open Forum: CMC Dossiers for

Biotech Products: Substance
with Style
11:00 Moderator:

Where Is It Written? ICH CTD Module 3!

Balanced mAb Process Development

Strategy to Enable Pre-Clinical Acceleration
Shamik Sharma, Ph.D., Principal Scientist,
Bioprocess R&D, Biotherapeutics Pharmaceutical
Sciences, Pfizer, Inc.
12:35 Technology
Workshops
Microbial Protein Secretion System

Yoshimi Kikuchi, Ph.D., Executive Professional and Group Manager, Recombinant Protein
Research Group, Research Institute for Bioscience Products & Fine Chemicals,
Ajinomoto Co., Inc., Japan
(Room 104C)
Advanced Materials for Single Use Systems
Mike Johnson, Business Development Engineering Manager, Entegris
Pet Peeves and Roadblocks in CMC:

11:30 Improving your Quality Submissions
through the Product Lifecycle
(Room 104B)
Marjorie Shapiro, Ph.D., Chief, Laboratory of

Molecular & Developmental Immunology, CDER,
US FDA
12:00
Preparing Effective Module-3

Challenges and Opportunities
Roman Drews, Ph.D., Senior Director Regulatory

Affairs, LFB USA and Former Regulatory Scientist/ (11:45 ) Accelerated and Cost Effective
Team Lead, Office of Blood Review and Research, Development of a Novel Biologic in a Virtual
CBER, US FDA
Environment: A Better Paradigm
Laurence Blumberg, M.D., Founder & Chief
Operating Officer, Syntimmune, Inc.
Fast Trak Your Molecule to Market: When, Why and How to Outsource
Biomanufacturing
Patrick Guertin, Global Technical Manager, GE Healthcare
(Room 104A)
An Integrated BalanCD CHO Media Solution for Early Therapeutic

Antibody Development, Scale-Up and Commercial Supply
Jessie Ni, Ph.D, CSO, Irvine Scientific
Yves Durocher, Ph.D, Research Office, National Research Council Canada
(Room 103)
12:35
1:05
Reveal Information that Gives Insights New Approaches to Sub-Visible Particle

Characterization
Dr. Josefina Nilsson, Head of EM services, Vironova AB
Dr. Gustaf Kyhlberg, Ph.D., Product Manager MiniTEM, Vironova AB
(Room 102B)
16

Cell Culture
(Room 208)
(Room 209)
2:25 (2:15 ) Chairpersons Remarks
Charles Sardonini, Ph.D., Director, Process Engineering/

Development, Genzyme, a Sanofi Company
Improving Process Understanding, Control, and

Productivity at Clinical and Commercial Scale
2:30 (2:20 ) Developing
Robust Control Strategies for

Sustainable Upstream Commercial
Manufacturing
Patrick M. Hossler, Ph.D., Principal Research Scientist,

Process Sciences, AbbVie Inc.
Featured Presentation
Managing for Best Economy - Closing Technology Gaps and
Integrating Upstream and Downstream Process Development
Kartik Subramanian, Ph.D., Principal Scientist and Group Leader,

Manufacturing Sciences, AbbVie
3:00 (2:45 ) Optimization of Productivity and Targeted
Michael A. Bennett, MSc., Scientist, Process Development, Patheon
3:30 (3:10 ) Driving
Value for Cell Culture Commercial

Manufacturing Through Process Understanding
and Continuous Improvements
Nefiola Kaso, Senior Scientist I, Manufacturing Sciences, AbbVie
Mark Yang, Ph.D., Director of Fill Finish Development, Sanofi Genzyme
Drug Product Case Studies: Residual Moisture,

ADCs and Freeze Dryer Characterization
Case Study: Residual Moisture in Lyophilized Drug
Product, How Much Is Too Much?
Gnter Jagschies, Ph.D., Senior Director, Strategic Customer

Mark Yang, Ph.D., Director of Fill Finish Development, Sanofi
Relations, GE Healthcare Life Sciences, BioProcess Division, Sweden Genzyme
Integrating Novel Materials, Technologies, and

Strategies for Next Generation Purification
Performance of Next Generation High Capacity
Anion Exchange Media in mAb Purification
Modulation of Product Quality Attributes

of a Phase III IgG Utilizing the Ambr15 Platform

Debola Banerjee, M.Tech, Engineer II, Purification Development,

Genentech, Inc.
Enabling Manufacturing of Affordable Biologics

Through the Use of Protein A Membrane in a Single Use
Purification Strategy
Renaud Jacquemart, Ph.D., Principal Scientist, Process Sciences,

Natrix Separations Inc.
Evaluation of Quality Attributes of an Antibody-Drug

Conjugate (ADC 1) Following Extended Storage in a
Stainless Steel Container
Amy Leung, Scientist I, ImmunoGen, Inc.
Freeze Dryer Characterization to Enable Modeling:

Going Beyond the FAT
Anthony Gudinas, Principal Scientist, Pharmaceutical Sciences,

Pfizer, Inc.
(3:35 ) Successful
Application of a Scale-Up Strategy from

Bench-Top to Pall Allegro STR Bioreactors
Alvin Nienow, Ph.D., Emeritus Professor of Biochemical Engineering,

School of Chemical Engineering, University of Birmingham,
United Kingdom
4:00
Novel Single-Use Applications in Cell Culture

Sponsored by:
5:00
Scale-Up to 2000L Single-Use Bioreactors, A Case

Study in Reactor and Process Characterization
Nienke Vriezen, Head, Upstream Biotechnology,
Synthon Biopharmaceuticals BV
5:30
Developing Single Use Technology (SUT)

Cell Expansion rocess to Improve Legacy
Cell Culture Processes
Jean Hsu, Process Engineer III, MSAT Lab, Sanofi
6:15
17
Novel Impurity Removal and Validation Strategies

to Accelerate and De-Risk Development
A Comprehensive Impurity Removal Strategy for
Protein A to Simplify mAb Purification Process
for Early Phase Molecule
STAT Panel Discussion
(Theater Zone in Exhibit Hall A)

President Clinton or President Trump: What Our Next
President will Mean for Biotech and Pharma
Moderator: Rick Berke, Executive Editor, STAT (STATnews.com)

Panelists:
David P. Meeker M.D., Executive Vice President, Head, Sanofi Genzyme
Mason Tenaglia, Vice President, IMS Institute for Healthcare
Leveraging Mechanistic Chromatography Modeling
Informatics, Payer & Managed Care Insights
Dylan Scott, Washington Correspondent, STAT
to Streamline QbD Process Validation of Biologics
James A. Patch, Ph.D., Principal Engineer, Purification Development, Damian Garde, National Biotech Reporter, STAT
Kathleen Weldon Tregoning, Senior Vice President, Corporate Affairs,
Genentech, Inc.
Biogen
Lu Wang, Ph.D., Senior Scientist, CMC Downstream,
Teva Pharmaceutical Inc.
Party In the Park (The Lawn on D)


(Room 212)
2:25
Patrick Robertson, Ph.D., Director, Program Design, FUJIFILM

Diosynth Biotechnologies U.S.A., Inc.
Manufacturing for Late Stage Development and

Commercial Products Sponsored by:
2:30
3:30
Melissa Morandi, Vice President, Global Quality,

Aegerion Pharmaceuticals
Quality Risk Assessment and QC

Testing Strategies
Joshua Speidel, Ph.D., Managing Director, Commercial Practice

Lead, Latham BioPharm Group, Inc.
Funding Strategies for Early Stage Companies
Risk Assessment across the Entire Quality System

and Company
Funding a Therapeutic-Focused Company through Angels:

The Good, The Bad and the Ugly
Manufacturing for Late Phase Development
Risk Impact of Multivariate Predictive Models
PANEL DISCUSSION: How to Overcome the Funding Gap
Melissa Morandi, Vice President, Global Quality,

Marjorie Vargas, Process Sciences, FUJIFILM Diosynth

Biotechnologies U.S.A., Inc.
Andrew Lenz, Senior Manager, Global Process Analytics, Biogen
Implementation of Comprehensive End to End Process

Monitoring for Understanding Variability and Improving
Product Robustness
Analytical Testing Strategy for Kadcyla Cleaning

Validation and Lessons Learned from ADC Drug Product
Transfer to a CMO
Syama Adhibhatta, Associate Director Process Modelling &

Analytics, Biologics Manufacturing Sciences and Technology,
4:00
(Room 207)
Bioreactor Process Improvements in a Legacy

Perfusion-based Process
Jiayi Zhang, Ph.D., Manager Process Engineering Development,

MSAT, Genzyme
3:00
Early Stage Biologics and Companies
(Room 213)
Lan Dai, Ph.D., QC Associate Scientist, Global Biologics Quality

Control, Genentech Inc., A Member of the Roche Group
Barbara Fox, Ph.D., CEO, Tilos Therapeutics
for Biotech Start-ups and Emerging Companies
What is the impact to the industry, when so many great start-ups

with great technologies fail in early stages due to a gap in earlystage funding?
How can the biopharma industry stimulate innovation without
initial financing for companies to help them succeed?
Is there any middle ground between financiers interests in later
stage companies (ph. 2 and beyond) and emerging companies
need for cash in order to even survive to phase 2?
Moderator:
Joshua Speidel, Ph.D., Managing Director, Commercial Practice
Lead, Latham BioPharm Group, Inc.
Panelists:
Barbara Fox, Ph.D., CEO, Tilos Therapeutics
Ohad Karnieli, Ph.D., Co-founder & Chief Technology Officer,
Karnieli Ltd., Israel
Tyler G. Merkeley, Health Scientist, Chief of Staff (Acting) and Head
of Special Projects & Portfolio Management, BARDA
STAT Panel Discussion (Theater Zone in Exhibit Hall A)

5:00
President Clinton or President Trump: What Our Next President will Mean for Biotech and Pharma
Moderator:
Rick Berke, Executive Editor, STAT (STATnews.com)
Panelists:
David P. Meeker M.D., Executive Vice President, Head, Sanofi Genzyme
Mason Tenaglia, Vice President, IMS Institute for Healthcare Informatics, Payer & Managed Care Insights
Dylan Scott, Washington Correspondent, STAT
Damian Garde, National Biotech Reporter, STAT
Kathleen Weldon Tregoning, Senior Vice President, Corporate Affairs, Biogen
6:15
Party In the Park (The Lawn on D)

18
FRIDAY, OCTOBER 7, 2016

Cell Culture
(Room 209)
7:15
8:00
Renaud Jacquemart, Ph.D., Principal Scientist, Process Sciences,

Natrix Separations Inc.
Sid Advant, Ph.D., Head, Biologics, Kemwell Biopharma
Development and Production of New Modalities

8:05
Panel Discussion
Panel Discussion - Future of Biomanufacturing
Needs and Solutions
Late Stage Cell Culture Process Development for

a Bispecific Antibody Following QbD Approach
Jiuyi Lu, Ph.D., Scientist, BioPharmaceutics Development, Sanofi
8:35

(Room 208)
Moderator: Natraj Ram, Ph.D., Associate Director, Purification,

Flublok Manufacturing using Baculovirus

Wafaa Mahmoud, Ph.D., Manager, Product
Soham Bhatt, Technical Development Engineer, Biogen
Case Studies: Visual Particles, Process

Characterization and Scale-up
A Biopharmaceutical Industry Perspective on the Control of Visible
Particles in Biotechnology Derived Injectable Drug Products
Maryam Mazaheri, Associate Project Manager - CMC,
MedImmune, Inc.
The Role of Equipment and Container Characterizations

in Process Scale Up in Dual Chamber Syringe
Development, USP, Protein Sciences
Soham Bhatt, Technical Development Engineer, Biogen
Plenary Keynote Speaker (Theater Zone, Exhibit Hall A)

9:15
Innovation & Customer Centricity
Steve Wozniak, Co-founder, Apple Computer Inc.

10:15
11:00

Plant-Based Manufacturing for Ebola Therapeutics
David L. Boucher, Ph.D., Health Scientist, Division of CBRN

Countermeasures, Biomedical Advanced Research and
Development Authority (BARDA), Office of Assistant Secretary for
Preparedness and Response (ASPR), U.S. Department of Health &
Human Services (HHS)
Innovations in High-Throughput Development

& Process Modeling
Chairperson: Renaud Jacquemart, Ph.D., Principal Scientist, Process

Sciences, Natrix Separations Inc.
In-silico Process Characterization of Filling Operations:

Predicting Quality Attributes from First Principles
Will Johnson, Ph.D., Principal Engineer, Digital Integration &
Predictive Technologies, Amgen, Inc.
A Holistic Approach to Inform Bioprocess Design

and Operation: Case Studies Illustrating the
Application of Ultra Scale-Down Tools for High Throughput
Bioprocess Studies of Linked Recovery Unit Operations
Andrea Rayat, Senior Enterprise Fellow, Bioprocessing, MSC.,
The Advanced Centre for Biochemical Engineering, Department of
Biochemical Engineering, University College London, United Kingdom
11:30
Solving Production Challenges of

Difficult-to-Express Proteins with a Scalable,
Continuous Manufacturing Bioreactor: A Case Study
Modulation of Protein Biophysical Properties

with Small Molecule in Purification and
Formulation
Wireless Automated Glove Integrity Tester (WAGIT)

for Isolator Technology
High Titer Production of Knob-In-Hole Bispecific

Antibodies in E.coli
Development and Integration of Process

Models into Legacy Manufacturing Processes
to Improve Performance and Product Quality
Biopreservation Considerations for Live-cell Fill, Finish

and Patient Administration
Scott Waniger, Vice President, BioServices Division,

Cell Culture Company
12:00
James Giulianotti, Senior Research Associate, Early Stage Cell

Culture, Genentech, Inc.
Francis Insaidoo, Ph.D., Senior Scientist, Process Development and

Enfgineering, Merck & Co., Inc.
Nathan Lee, MSc., Senior Engineer, Manufacturing Technology,

Zach Price, Filling Engineer, Genentech, A Member of the

Roche Group
Alireza Abazari, Ph.D., Senior Application Scientist,

BioLife Solutions
12:35
1:05
Networking Luncheon and Last Chance for Exhibit Hall Viewing (Exhibit Hall A)
19
FRIDAY, OCTOBER 7, 2016

(Room 212)
7:15
8:00
Workshop with Light Continental Breakfast
Rajesh Beri, Ph.D., Technical Director Research & Technology,

BioManufacturing, Lonza Biologics

and Aging Manufacturing Facilities
8:05 A New Stainless Steel Manufacturing Facility:
Flexibility without Complexity
Joseph Neal, Scientist I, MS&T, Supply Biologics, AstraZeneca

8:35 Enabling Flexibility through Automation for a New
Manufacturing Facility
Ryan Hogan, Scientist I, Manufacturing Sciences and Technology,

AstraZeneca
Ganapathy Gopalrathnam, Senior Research Scientist,

Lilly Research Laboratories, Eli Lilly & Co.
Formulation Strategies for Biologics

Metal-catalyzed Oxidation of Polysorbates in Histidine
Buffer System
Digital Industrial and the Factory of the Future

Jennifer Staffin, GE Healthcare
(Room 206B)
12:35 Technology
Ganapathy Gopalrathnam, Senior Research Scientist, Lilly Research

Laboratories, Eli Lilly & Co.
Workshops
Revisiting Achilles Heel of PBS: Modified PBS and Freeze

Thaw Stability of Monoclonal Antibody
Tatyana Mezhabovsky, Ph.D., Principal Scientist, BioFormulations
Development, Sanofi R&D
Keynote Speaker (Theater Zone, Exhibit Hall A)

9:15
7:15 Technology
(Room 213)
Innovation & Customer Centricity
Unlocking Downstream Efficiency
Gnter Jagschies, Ph.D., Senior Director,

Strategic Customer Relations, Uppsala, Sweden
(Room 104A)
Steve Wozniak, Co-founder, Apple Computer Inc.

10:15
11:00

and Aging Manufacturing Facilities (continued)
Chairperson: Surendra Balekai, Senior Global Product Manager,

BioProduction, Thermo Fisher Scientific
Pediatric Formulation Considerations
Anant N. Sharma, Formulation Scientist, Lilly Research Laboratories,

Eli Lilly & Co.
Innovative Strategies Optimizing Capacity and Flexibility

in the Amgen, RI Biomanufacturing Plant
Jessica Morse, Senior Manager Cell Culture, Amgen
11:30
Experimental Data Supporting Risk-Based

Biopharmaceutical Facility Design Approaches
Jeffrey Johnson, New Technology Lead and Director, Center for

BioManufacturing Sciences, Merck & Co., Inc.
12:00
Evaluating Risk of Components in Aging Facilities
12:35
Improving Single Use Bioreactor Design and Process

Development: New Research Towards Intensifying SeedTrain and Scale-up Methods Using 5:1 Turn-Down
Christopher Smalley, Ph.D.,Senior Consultant, ValSource
Pediatric Formulations and Challenges Manufacturing

Pediatric Dosages
Michael Colacino, Senior Director, Global Manufacturing,
Analytical Strategies for Biologic Combination Therapies
Lynn Gennaro, Ph.D., Associate Director, Analytical Development and

Quality Control, Genentech
Ben Madsen, Ph.D., Process Development Engineer II,

Thermo Fisher Scientific
1:05
Networking Luncheon and Last Chance for Exhibit Hall Viewing (Exhibit Hall A)
20
FRIDAY, OCTOBER 7, 2016 (CONTINUED)

Cell Culture
2:25
(Room 209)
Patrick M. Hossler, Ph.D., Principal Research Scientist, Process

Sciences, AbbVie Inc.
Impact of Process Conditions

on Product Quality
2:30
3:30
4:00
Natraj Ram, Ph.D., Associate Director, Purification, Manufacturing

Process Integration & Intensification
Julie Zhu, Ph.D., Associate Director,

Pharmaceutical Development & Manufacturing Sciences (PDMS),
Drug Product and Fill-Finish Strategies

for Cell Therapy Products
Expanding the Glycan Code for Mammalian

Expressed Glycoproteins
Evolution, Process, and Challenges of Viral Filtration
Process Conditions and Misincorporations
Resin Multi-Product Use Past, Present, and Future

Yolanda Ng, Purification Pilot Plant Technical Specialist,
Late Phase Fill-Finish Process Development

Challenges-Case Study for A Cell Therapy Product
Scale-up and Production Challenges in Cell Therapy Filling
Rashmi Kshirsagar, Ph.D., Director, Technical Development, Biogen
High Concentration Ultrafiltration: Effect

of Tangential Flow Filtration Cassette Design
and Operating Parameters on Process Performance
Production of Sialylated Monoclonal

Antibody in CHO Cells
INTEGRATED DOWNSTREAM PROCESSING

ROUNDTABLE DISCUSSION
Cell Therapy Fill & Finish: New Challenges and Possible

Innovative Solutions
Patrick M. Hossler, Ph.D., Principal Research Scientist, Process

3:00

(Room 208)
Bruno Figueroa, Ph.D., Associate Research Fellow, Pfizer
Elemental Metals and Impact on Product

Quality Attributes
Yves Durocher, Ph.D., Research Officer, Antibodies and

Bioprocessing, National Research Council Canada
Dayue Chen, Ph.D., Senior Research Advisor, Bioprocess Research

and Development, Eli Lilly and Company
PTDUO, Genentech, Inc.
Fill & Finish Operations for Cell Therapy Products:

Challenges and Opportunities
Maria del Pilar Redondo, Pharm.D., Senior Director, Technical

Operations, TiGenix, Spain
Julie Zhu, Ph.D., Associate Director,

Pharmaceutical Development & Manufacturing Sciences (PDMS),
Brian Murphy, Ph.D., Director of Bioprocess Development,
Celgene Cellular Therapeutics
Dharmesh Kanani, Senior Scientist, Downstream Development &

Operations, Teva R&D Biologics CMC TBU, Teva Pharmaceutical Inc.
Future of Automation, Integration and Intensification Technical and Platform Compatibility - A Wholistic and
Mojular Approach to Process Integration
Ohad Karnieli, Ph.D., Co-founder & Chief Technology Officer,

Karnieli Ltd, Israel
Moderator: Natraj Ram, Ph.D., Associate Director, Purifiaction,

4:30
21
Close of Conference
FRIDAY, OCTOBER 7, 2016 (CONTINUED)

(Room 212)
2:25
(Room 213)
Nandu Deorkar, Ph.D., Vice President, Research and Development,

Strategies to Control Raw Material Variability and to

Improve Supply Chain Transparency and Security
Sponsored by:
2:30
Mike Brewer, Product Management Leader, Thermo Fisher Scientific
Analytical Strategies for Biosimilars

and Glycan Profiling
Controlling Raw Material Variability Improves the

Biopharmaceutical Process Consistency and Product
Quality
Developing 1D Proton NMR Analysis for Higher Order

Structural Similarity of Therapeutic Antibodies:
Application of Spin-Diffusion Editing
Evaluation of Advanced Media/Feed Characterization

Methods for an Improved Understanding of Media/Feed
Variability
MoA Reflecting Bioassays to Confirm Biosimilarity
Visualizing Raw Material Genealogy
Analytical Strategies for Biosimilars and Glycan Profiling
Protecting the Patient through Enhanced Supply Chain

Security
Analytical Strategy for N-Glycan Profiling Analysis for

mAbs Comparison of a High Throughput Method vs a
High Resolution Method
Nandu Deorkar, Ph.D., Vice President, Research and Development,

3:00
Qin Zou, Ph.D., Senior Principal Scientist, Analytical R&D, Pfizer, Inc.
Ulrike Herbrand, Ph.D., Scientific Officer, Charles River

Biopharmaceutical Services GmbH, Germany
Rajesh Beri, Ph.D., Technical Director Research & Technology,

BioManufacturing, Lonza Biologics
3:30
Roland Zhou, Process Analytics Engineer III, Biogen
4:00
Wesley Straub, Ph.D., Senior Product Manager,

Rob Welsh, Vice President, Bioprocessing Segment Solutions,

VWR and Rx-360 International Pharmaceutical Supply Chain
Consortium Board Member & Co-Chair of Supply Chain Security
Steering Committee
4:30
Melissa Schwartz, Scientist II, Analytical Science, Boehringer

Ingelheim
Close of Conference
22
SPONSORSHIP & EXHIBITION OPPORTUNITIES

WHO WILL YOU MEET?
GEOGRAPHY
Head/Lead/Partner/
Strategist/Principal
19%
Associate/Analyst/
Account Executive/
Specialist
24%
US & Canada
86%
5%
Europe 10%
Other
Cell Culture Company

Charles River
Charter Medical
Chemglass Life Sciences
CMC Biologics
Cook Pharmica
Corning Incorporated
CPC
Custom Biogenic Systems
Cytovance Biologics
Distek, Inc
DNA 2.0
em-tec Flow Technology LP
Emergent BioSolutions
Entegris
Enzo Life Sciences
Eppendorf
Essential Pharmaceuticals
Eurofins Lancaster Labs
Evonik Corporation
Farrar Scientific Corporation
Filtrox AG
Finesse Solutions
Flownamics
FrieslandCampina Ingredients
Fujifilm Diosynth Biotechnologies
4%
Academia/Govt.
Consultant/Agency
1%
26%
Solution Provider
31%
Pharma/Biotech
Drug Delivery
16%
(Sr) Dir/Scientist/Engineer
GE Healthcare
Genetic Engineering &
Biotechnology News
Gyros US, Inc
Hamilton Company
IDBS
ILC Dover
Infors USA
Integra Companies
Integrated Project Management
Company, Inc
Irvine Scientific
JNC Corporation
JSR Life Sciences
Kaiser Optical Systems
Kaneka
KBI Biopharma
Kemwell Biopharma
Kerry
Kuhner Shaker
Levitronix
LEWA Nikkiso America
Lonza
MabPlex
Malema Sensors
Malvern Instruments
Masy BioServices
MaxCyte
Meissner Filtration Products
MilliporeSigma
Molecular Devices
New England Controls
Nordson Medical
Nova Biomedical
Novasep
Novo Nordisk Pharmatech A/S
Oetiker, Inc..
optek-Danulat, Inc.
Pall Life Sciences
Paragon Bioservices
Parker domnick hunter
PendoTECH
Pfizer, One 2 One
ProMetic Biosciences
Purolite
Qosina
Refine Technology LLC
Rentschler Biotechnologie GmbH
Repligen
Roche
Saint-Gobain
Sandoz
SaniSure
Sartorius Stedim Biotech
SGS
Sm@rtline Data Cockpit
SpectrumLabs.com
Strain Measurement Devices
Tecan
Terumo BCT
Therapure Biomanufacturing
Tosoh Bioscience LLC
Toxikon Corporation
Transonic
Unchained Labs
VacciXell
Vironova AB
VR Analytical
Watson-Marlow Fluid Technology Group
West Pharmaceutical Services
WPI Biomanufacturing Ed. & Training Cntr.
WuXi AppTec / WuXi Biologics
YMC America, Inc.
YSI, Inc
Find out what the best level of sponsorship is for your organization
23
8%
Other
29%
2%
Rest of World 2%
ABL, Inc
Advanced Instruments
AdvantaPure / NewAge Industries
Agilent Technologies
Ajinomoto, Co., Inc.
Althea
ANGUS Life Sciences
Applikon Biotechnology
Aragen Bioscience
Asahi Kasei Bioprocess
Avid Bioservices
Axcellerate Pharma, LLC
BD
Beckman Coulter Life Science
Bend Research, a division of
Capsugel
Berkeley Lights, Inc
BIA Separations d.o.o.
Bio-Rad Laboratories
Bionova Scientific, Inc
BioTechLogic
Boehringer Ingelheim
Broadley James
BTEC/North Carolina State University
Catalent
8%
5%
VP/SVP/EVP
14%
CRO
C-Level
Manager/Scientist/
Engineer
APAC
EXHIBITORS (As of July 7, 2016)
COMPANY TYPE
9%
1,800+
BPI attracts more than 1800 attendees each year
providing you more networking and business
opportunities than any other bioprocessing event
on the market.
JOB LEVEL
A-L: JENNIFER WICKETT 508.614.1672 jwickett@ibcusa.com | M-Z: KRISTEN SCHOTT 508.614.1239 kschott@ibcusa.com
"This show brings in the endusers - we get great quality leads"

- Kelly Jakinovich, Associate Sales Engineer,
Saint Gobain
"We get more good leads at BPI

than any Show including
Interphex"
- Gary Gaudet, Clean Market Manager, LEWA, Inc.
"BPI is a great opportunity to

meet leaders, and innovators in
this industry."
- Holzer Margit, VP R&D and Technology,

Novasep
MEET THE PEOPLE BEHIND THE PRODUCTS & GET THE ANSWERS YOU NEED
EVENT PARTNERS
SESSION SPONSORS
The Life Sciences business of GE Healthcare provides a wide range of bioprocessing solutions for the development and manufacture of
high-quality biotherapeutics and vaccines. Using our expertise, we support our customers in increasing speed to market, while reducing costs
and improving performance in drug manufacturing. As a provider of high-quality products, technical and commercial services, as well as
design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.
Pall Life Sciences provides process, pilot and laboratory filtration, separation, purification and fluid handling devices,
systems and services, with single-use systems available for all unit operations from cell culture through final
formulation and filling. Based on Palls long history of providing quality equipment for the biopharmaceutical, vaccine
and cell therapy industries, all products - whether standard or customized to match users exact process needs - are backed up with extensive documentation
and experience in extractables, leachables and particulate validation. Fully automated single-use systems allow process control and data acquisition to
meet or exceed the standards expected from traditional fixed equipment. New product highlights include microcarriers, pyrogen-free vials and a range of
pharmaceutical packaging.
PRESENTATION/TECHNOLOGY WORKSHOP SPONSORS
s a total solution provider, Sartorius Stedim Biotech merges one of the broadest portfolios of single-use
A
components, hybrid or traditional stainless steel systems, and services in the market. Our integrated
solutions cover fermentation, cell cultivation, filtration and fluid management as well as purification and
lab technologies. Visit booth #717 to learn more about all Sartorius Stedim Biotech has to offer!
PLATINUM SPONSORS
LUNCHEON PRESENTATION SPONSORS
oche Custom Biotech supplies reagents, analytical methods, and services customized to meet the quality and regulatory
R
needs of our customers. We offer customization, contract development, and manufacturing in nearly all fields of our
portfolio, including custom antibodies and enzymes. Our product portfolio includes a wide range of GMP manufactured
products used in inprocess quality control testing, enzymes for dissociating cells from primary tissues, downstream
proteases, and biocatalysts. With a portfolio of over one thousands products, we can specifically modify existing products,
custom manufacture to your needs, or provide consultancy on the development of completely new items.
GOLD SPONSOR
WELCOME BREAKFAST PRESENTATION SPONSOR
OPENING NIGHT CELEBRATION OF SCIENCE RECEPTION CO-SPONSOR

io-Rad Laboratories is a leading global provider of innovative tools to the life science and clinical diagnostics markets with
B
more than 60 years of experience, where the companys products are used for scientific discovery, drug development, and
biopharmaceutical production. Bio-Rads Life Science Group has long served the bioprocessing industry with innovative
process separation technologies. Bio-Rad provides a full line of scalable process chromatography resins to meet your
purification needs with worldwide access and personalized service and support.
SITE TOUR SPONSORS
SILVER SPONSORS
Fujifilm Diosynth Biotechnologies is a full service Contract Development & Manufacturing Organization (CDMO)
focused in clinical & commercial cGMP contract manufacturing of complex recombinant proteins, vaccines,
antibodies, fusion proteins, etc.
BPI BIOBREW SPONSOR
BOSTON BREWHOUSE SPONSOR

BPI THEATER SHOWCASE SPONSORS

BRONZE SPONSORS
WIFI SPONSOR
LOUNGE SPONSOR

FIND OUT WHAT THE BEST LEVEL OF SPONSORSHIP IS FOR YOUR ORGANIZATION
A-L: JENNIFER WICKETT 508.614.1672 jwickett@ibcusa.com | M-Z: KRISTEN SCHOTT 508.614.1239 kschott@ibcusa.com
24
EXHIBITION & EVENT ACTIVITIES
THEATER ZONE LOCATED IN THE HEART OF THE EXHIBIT HALL
The Theater Zone stage in the exhibit hall will provide an information-packed agenda of
industry-critical information in a variety of formats including presentations, panel discussions,
product demonstrations, Q&A sessions, interviews and much more. Theater Zone speakers and
attendees will share a communal learning experience as they present, discuss, and debate the
latest scientific and business trends impacting the biotech and pharmaceutical fields. Please
visit the conference website for a full agenda of Theater Zone presentations and activities.
If you are interested in participating in the Theater Zone or you would like to propose a
speaker, panel discussion topic or interview subject, please contact Michael Keenan.
mkeenan@ibcusa.com or call 949-276-2634.
OPENING NIGHT RECEPTION

CELEBRATION OF SCIENCE
WED, OCT. 5TH | 4:30 pm - 6:30 pm
RECEPTION IN THE EXHIBIT HALL

Kick off your conference experience at the Opening Night Party to celebrate
the launch of Biotech Week Boston! Explore our Celebration of Science
theme with a taste of molecular gastronomy from Bostons celebrity chefs.
The party will feature Dueling DJs, from the theater zone while you catch up
with colleagues and friends, network with attendees, exhibitors and sponsors.
Participate in several interactive activities and/or relax in one of the themed
lounge areas. Enjoy a fun evening with food, drinks and entertainment.
BPI "BIO BREW" EVENT TUES, OCT. 4
TH
| 7:30 pm -10:30 pm
Catch the shuttle outside the BCEC for the BPI BioBrew Networking Event @ Harpoon Brewery
(limited capacity; registration required)
Sponsored by
SITE TOUR TO UNIQURE TUES, OCT. 4
TH
Sartorius will be hosting a Site Tour to the UniQure Facility in Lexington, MA
Buses will leave the Boston Convention & Exhibition Center at 1:00pm and will return at 6:00pm.(limited
capacity; registration required)
Sponsored by
SITE TOUR TO REPLIGEN TUES, OCT. 4
TH
| 1:00 pm to 4:30 pm
OPUS Manufacturing Facility in Waltham, MA. Sponsored by

How Do You Pre-Pack a Chromatography Column?
Repligen invites you to a tour of its manufacturing facility in Waltham, MA to see how OPUS Pre-packed
Columns are produced for use by biopharma companies worldwide. The tour will guide you through three
state-of-the-art ISO700 packing clean rooms, and demonstrate stringent materials warehousing, preparation,
packaging, and quarantine processes. Break-out sessions with subject experts will also be available.
Bus will depart Boston Convention Center at 1pm and arrive back at 4:30pm. Tour will include a light cocktail
& hors d'oeuvres reception (limited capacity; registration required)
25
EXHIBITION & EVENT ACTIVITIES

WOMEN'S EXECUTIVE LEADERSHIP DINNER
WED, OCT. 5TH | 6:45 pm - 9:30 pm
Women in positons of senior leadership within life sciences have truly completed an
awesome feat in a male dominated space. At this years Womens Executive Leadership
Dinner, we honor these women by recognizing their accomplishments across various
stages of the life science ecosystem. Join us for an inspiring and insightful discussion
over dinner as executives share their journeys of rising to the ranks of senior leadership
in life sciences. Learn how to find the right mentor for your desired career path. You
dont want to miss out on this opportunity to engage with women that are breaking
barriers and taking life science to heightened levels of success.
RECOGNIZING EXCELLENCE IN BIOPROCESSING

WED, OCT. 5TH | 7:00 pm - 10:00 pm | Room 210AB
2016 BIOPROCESS INTERNATIONAL AWARDS

GALA AWARD DINNER & CEREMONY
Where the heart, technology and business of science gets
the recognition it deserves. Join BioProcess International
Magazine as we honor the individuals, organizations
and technologies that have significantly impacted, and
advanced the efficiency of biotherapeutic development and
manufacturing process. Dont miss this years Red Carpet
Reception. Enjoy a sit down dinner and experience the
presentation of the 2016 BioProcess International Awards.
Have some fun and laughs with a very special comedy show
you will be talking about for months to come! Complete
this special evening with a Martini and Champagne Dessert
reception.
Are you nominated?
Go to www.bioprocessintl.com/awards and submit your
nomination today! Space is limited, so make sure to make your
reservation for the award ceremony while registering for the
conference. (Separate registration and fee required)
Sponsored By
PARTY IN THE PARK

THURS, OCT. 6TH | 6:00 pm - 10:00 pm
Close out the last night with a bang at Party In the Park. Come and
party at a first-of-its-kind outdoor interactive space in Boston, The
Lawn on D.
Hosted & Organized By
This unique outdoor interactive experience will be filled with Bocce

courts, ping-pong tables, cornhole, KanJam games. Party In the
Park will feature a Main Stage under the tent with a special guest
performance from Don Felder, formerly of the Eagles.
There will be great food and drinks, food trucks, interactive activities
for everyone. These are the reasons why Party In the Park promises
to be a night to remember!
This event is free for all attendees, but an advance RSVP is required
to reserve your spot.
26
CALL
800.390.4078 or
+1.941.554.3500
EASIEST:
WAYS TO
REGISTER
BPIEvent.com
Industry Rates
Standard Rate After Sept. 2, 201
4-Day Pass: Pre-Conference Symposium (Tues) + 3-Day Main Conference (Wed-Fri)
$3,299
4-Day Access: 2-Day Training Course (Wed-Fri) + 2-Day Main Conference (Thurs-Fri)
$3,299
3-Day Access: Main Conference (Wed-Fri)
$2,599
2-Day Training Course Only (Tues-Wed)
$1,999
Group Rates (Send 4 or more)
TRAIN YOUR TEAM AT BPI AND SAVE

With 225+ speaker presentations, 100+
scientific posters, 160+ exhibitors and 1700+
attendees to meet onsite, consider sending
your whole team to BPI. Register your team
of 4+ to receive an additional $400 savings/
person off the current industry rate. Secure
your teams place today by contacting
GROUP SALES MANAGER Brian Schiff at
bschiff@iirusa.com or 646-895-7444.
Standard Rate
4-Day Pass: Pre-Conference Symposium (Tues) + 3-Day Main Conference (Wed-Fri)
$2,899 per person
4-Day Access: 2-Day Training Course (Wed-Fri) + 2-Day Main Conference (Thurs-Fri)
$2,899 per person
3-Day Access: Main Conference (Wed-Fri)
$2,399 per person
Academic/Government Rates are Available

Full-time employees of a government organization, university and universityaffiliated hospital are eligible to take advantage of up to 40% savings off industry
rates. Visit our website for more details and academic/government pricing
Conference Venue:
Boston Convention and Exhibition Center
EMAIL
reg@ibcusa.com
415 Summer St., Boston, MA 02210

Phone: 617-954-2000
web: http://massconvention.com/about-us/contact-us/boston-convention-exhibition-center
Hotel Accommodations:
Aloft Boston Seaport
401-403 D Street, Boston, MA 02210

Special Room Rate:
Central Reservations: (877) 462-5638
$349/night plus tax
Reservations Direct: (617) 530-1600
When calling Reference: Boston Biotech Week
Web link: www.starwoodmeeting.com/events/start.action?id=1601185856&key=3B2CF596
Boston Park Plaza
50 Park Plaza at Arlington Street, Boston, MA 02116

Special Room Rate:
$329/night plus tax
Reservations Direct: (617)-426-2000
When calling Reference Code: Biotech Week
Web link:
bostonparkplaza.reztrip.com/rt/ext/promoRate?property=100&mode=b&pm=true&sr=128406&vr=3
Omni Parker House
60 School Street, Boston, MA 02108

Special Room Rate:
$319/night plus tax
Reservations Direct: (617) 227-8600
When calling Reference Code: Biotech Week
Web link: www.omnihotels.com/hotels/boston-parker-house/meetings/biotech-week-boston
PRESENT A POSTER TO SHOWCASE

YOUR COMPANYS LATEST RESEARCH
Any registered attendee may present a poster for display
inside the Exhibit Hall at BPI. Presenting a poster is a
great way to share your companys latest research with the
global bioprocessing industry. Submit your poster abstract
online by September 2, 2016.
Poster Fee: $125 for Industry, Complimentary for
Academic/Government
For full details regarding the conference venue, hotel, cancellation and substitution policy, visit BPIEvent.com
Early Registration & Group Discounts Available: BPIEvent.com

B16171brochure PDF

Transféré par

Informations du document

Titre original

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

B16171brochure PDF

Transféré par

Droits d'auteur :

Formats disponibles

BioProcess International

Conference & Exhibition

Conference: October 4-7, 2016

THE LARGEST BIOPROCESSING EVENT

The largest exhibition

THE GLOBAL MEETING PLACE FOR BIOPROCESSING

Improve integration, productivity and

Achieve clinical and commercial success by

Stay at the forefront of bioprocess

Accelerate your drug product to

"BPI was a great success and I absolutely enjoyed every

"BPI was a great, great conference. I enjoyed the

"This conference is a great place to meet the

Saeko Tanaka, Bioprocess Engineer, Chugai Pharmaceutical Co., Ltd, Japan

Kelvin Lau, Senior Process Engineer, Abbott

For up-to-date program information and new abstracts, visit: www.BPIevent.com

ANALYTICAL, FORMULATION AND QUALITY

CELL CULTURE & UPSTREAM PROCESSING

RECOVERY & PURIFICATION

DRUG PRODUCT MANUFACTURING & FILL-FINISH PROCESSING

EARLY STAGE BIOLOGICS AND COMPANIES

Register Early for Best Savings www.BPIevent.com 800-390-4078

Supply Chain Security and Transparency

Cell-Based ImmunotherapiesFrom Concept to Commercialization

Wednesday, October 5, 2016 Main Conference

Exhibit Hall Hours: 4:30 pm-6:30 pm

Recovery & Purification

Optimizing the Transition into Early Stage

Innovation at the Interface of Upstream and

Integrated Continuous Processing

Future Technologies and Their Impact on

Analytical, Formulation & Quality

Manufacturing Optimization and Process

New Paradigms in Manufacturing Facilities

Analytical Testing Strategies

Improving Cell Line Development

Drug Product Strategies for Preifilled

Evolution in mAb Process Platforms

Best Practices for Leachables Testing and Microbial Monitoring

Womens Executive Leadership Dinner

2016 BioProcess International Awards Gala Dinner and Ceremony

Thursday, October 6, 2016 Main Conference

Recovery & Purification

Integration of Analytical Methodologies

Streamlining Transfers & Progression from

Drug Product Strategies for Biologics

Cell Culture Acceleration

Platforms and Novel Approaches

Primary Packaging Components and

Early Stage Biologics

Harmonization of Manufacturing Strategies

Integration of Analytical Methodologies and

Open Forum: CMC Dossiers

Quality Risk Assessment and

Funding Strategies for

Open Forum: Industry-Academia

Networking Luncheon in the Exhibit Hall

Evolution in mAb Process Platforms

Drug Product Case Studies:

Novel Single-Use Applications

Streamlining Transfers & Progression from

Manufacturing for Late Stage Development

Networking Refreshment Break in the Exhibit Hall

Wednesday, October 5, 2016 Main Conference

Thursday, October 6, 2016 Main Conference

Friday, October 7, 2016 Main Conference

Repligen will be hosting a site tour to it's OPUS facility in Waltham, MA

3:45 Partnering with Suppliers for Improvements; A Supplier Collaboration