Technology Transfer & Process Development

Technology Transfer
& Process Development
You have spent years in the laboratory developing
a promising therapeutic protein that not only has
tremendous market potential for your company but
also global value in terms of the treatment of an unmet
medical need. It has now come to that critical point
in the program where you must choose a CDMO to
take your therapeutic protein to the next level. But to
whom can you turn with your valuable product? Who
will take your therapeutic protein to that next level
while respecting your requirements and continuing to
involve you in the development process? Therapure
is your trusted partner for efficient technology transfer
and developing your manufacturing processes.

Therapure understands the time and effort

invested into your drug candidate.

It is our goal to learn from your experience through our

comprehensive Technology Transfer program that is
designed to quickly and effectively transfer materials
and to convey critical product knowledge from your
team to ours. Through the creation of a joint Technical
Project Team, we are able to effectively steer the
development and manufacturing program ensuring
your milestones are met.

Following project kick-off, Therapure’s extensive

development experience comes to bear as your
project is transferred to our labs.

Therapure can provide a variety of product

and process development services including
the creation of a stable cell line or the
optimization and scale up of your existing
manufacturing process.
Therapure has the experience
and service offerings for process
development and optimization

Molecular biology
n Vector design and construction
n Host cell line transfection, amplification and selection

Cell banking (RCB, MCB, WCB)

Upstream cell culture development

nM
 edia selection and screening
n Pre-culture optimization
n Cell density and product expression optimization
n 5L to 50L lab-scale cell culture capability

Midstream harvest development

nF
 iltration (NFF, TFF)
n Centrifugation

Downstream process development

nR
 esin screening, selection and initial scouting
n Chromatography column optimization and scale up
n Tangential Flow Filtration (TFF) operations
n Protein characterization
n Viral inactivation/removal procedures

Product & buffer formulation development

nB
 uffer composition development and stability testing
n Lyophilization cycle development and optimization
n Bulk and final product stability testing

Analytical method development your trusted partner

for contract protein development & manufacturing
n In-process and release testing

Therapure Biopharma Inc.

2585 Meadowpine Boulevard,
Mississauga, Ontario Canada L5N 8H9

Telephone: +1 905 286 6200

Fax: +1 905 286 6300

www.therapurebio.com