BPL 50 Year Brochure 4 22/3/04 5:10 pm Page 1
1980 s: Expansion of Demand
In 1982, a massive increase in capital expenditure took place.
At around £60 million, it allowed a large, modern manufacturing
unit capable of greater production of blood products to be built.
The size of the BPL site increased when Sir William Maycock sold
his house and grounds (which included an orchard). The factory
had to be designed so that it fitted into the local green belt of
leafy Hertfordshire7.
Norman Fowler, the Minister of Health at that time, laid the
foundation stone and the new, state-of-the-art factory was opened
by HRH the Duchess of Gloucester on 29th April 1987, providing
us with the highly recognisable wedge-like landmark structure we
see today.
The mid-1980s also saw a growth in staff number from about 200
to around 400 employees representing a variety of administrative,
financial and scientific disciplines. Many staff were drawn from the
nearby towns of Borehamwood and Watford. A further staff
increase to around 500 took place by the late 1990s and industrial
relations developed into one of partnership between BPLs
Executive and the trade union MSF (later Amicus).
A greater focus on Quality Assurance became a priority and a
range of specialist functions were introduced such as a dedicated
microbiology department to test the quality of the manufacturing
environment.
There were also key changes to the manufacturing process with
a greater emphasis on patient safety, improved aseptic filling
operations and sterile filtration of the product.
1990 s Commercial Development
In 1990, following the establishment of the internal market in the
NHS, Blood Products Laboratory changed its name to Bio
Products Laboratory, although the BPL acronym was retained.
At the same time the Government introduced a charging
mechanism for BPL products to NHS customers which all
became licensed and BPL became subject to medical
inspectorate visits.
In 1991, BPL received a special mention in the House of
Commons for its role in the Gulf War through providing special
immunoglobulin products as part of Operation Granby in
association with the Chemical Defence Establishment at
Porton Down.
In 1993, the CBLA was dissolved and BPL became part of the
newly formed special Health Authority: the National Blood
Authority (NBA). This brought BPL and IBGRL together with the
blood transfusion centres and donor collection service -
previously under Regional Health Authority control - to form the
National Blood Services. This change was to allow for greater
re-sourcing and national strategy.
The 1990s saw improved techniques for viral removal and
inactivation. A specially designed area of the factory — the Viral
Secure Area (VSA) — was established and solvent detergents
steps added to destroy a spectrum of blood borne viruses.
Further investments into buildings took place and dedicated
buildings for Engineering, laboratories and R&D were built in the
early 1990s.
In 1998 the theoretical risk of transmission of nvCJD resulted in
a major change for BPLs operations. The factory underwent a
major sanitisation exercise and plasma was purchased from
blood centres in the USA.
The Future
The future for BPL will be both consistent and constantly
CELEBRA TING FIFTY 50 YEARS OF ACHIEVEMENT
changing. BPL will continue primarily as a plasma fractionator
to supply IgG to the patient population. This will continue to be
BPLs biggest growth area as there is a shift away from
manufacturing Factor VIII and albumin at previous levels.
The next decade will see BPL operating in Europe and in the
USA, which will keep BPL evolving and adapting in response
to change.
The future holds much to look forward to and much to achieve.
Acknowledgements
This booklet was written by Tim Sandle. Those who assisted with the preparation
were: Iain Bradbury, Shruti Shah, Sarah Kingsland and Steve Davies.
Thank you to all BPL staff, past and present, who provided information and
photographs.
1 Source material: http://www.lister-institute.org.uk/scientific.htm
2 Source material: http://www.bath.ac.uk/ncuacs/guidei-k.htm#KekwickRA
3 Source material: BPL Staff Handbook, 1992
4 Source: Blood - An Epic History of Medicine and Commerce; Douglas Starr;
London: Little, Brown, 1999; ISBN 0316911461
5 Source: http://www.bloodbook.com/trans-history.html
6 Source: Alice Kidd in The Crest , Summer 1990
7 Source: Blood Products Laboratory: Long Term Management Plan, April 1987,
Building Design Partnership
Bio Products Laboratory Dagger Lane, Elstree, Hertfordshire, WD6 3BX UK
Tel: +44 (0) 20 8258 2342 Fax: +44 (0) 20 8258 2604 Web: www.bpl.co.uk
BPL 50 Year Brochure 4 22/3/04 5:11 pm Page 4

Foreword
A lot has happened in that time and you might characterize our
history as either constant or constantly changing. In the latter
category you may recall the fact that BPL came to Elstree as a
guest of the Lister Institute and eventually took over the site. We
have the evolutions in the product range with the additions of
special coagulation factors and immunoglobulins, the introduction
of new steps to make purer product, the introduction of steps to
eliminate viruses and to make safer product. Great strides, great
change.
A variety of external events, however, have thrown BPL and, indeed
the whole industry, into turmoil from time to time. Few will ever
forget the advent of non-A, non-B hepatitis and the emergence of
variant CJD, to name but two.
In addition, the demand for products has increased over the years
as more and more patients are successfully treated and are able to
live normal lives. To cope with this, the BPL infrastructure has
developed enormously to the state-of-the-art plant that we now
have, together with the new R&D, Technical, Engineering and
Warehouse buildings. As well as importing our basic raw materials,
BPL now export products to all corners of the world.
What is BPL
BPL is a not-for-profit organisation of the NHS and produces a
range of plasma derived therapeutic products.
The plasma is fractionated by a process which separates out the
plasma components into different product groupings. These
products include coagulation factors for the control of haemophilia
(A and B) and other inherited bleeding disorders; specific and non-
specific immunoglobulins (antibodies) for the treatment of people
born with weak immune systems; and albumin for those who need
a restoration of their circulating blood volume.
These products are distributed around hospitals in England and
Wales, with any excess sold on a global market with all proceeds
returned to the NHS.
The plasma is separated and purified by a process called Plasma
Fractionation. Plasma arrives at BPL frozen. After quarantine, the
plasma is sent for processing. The first product (cryoprecipitate) is
separated and is used to process the clotting factors. This is
performed by separating plasma from individual packs; crushing
Underlying these apparently never ending changes is the element of
constancy. We remain on the same rather pleasant site in rural
Hertfordshire. The raw material from which we make our products
is still fundamentally the same raw material, the process by which
we break that raw material into its component parts and extract it is
still basically the same process.
The number of people at Elstree may have increased dramatically
and while there is nobody is here today who was with BPL in 1954,
but there remains certain unchanging values to which we all adhere
- the desire to make products which are not only safe and
efficacious but which in every case save lives and which make a
difference, not just to the patients who receive them but to their
families and friends as well.
For 50 years, BPL has been making that difference and will
continue to do so into the future. Another 50 years? Who can tell,
but however far the future of BPL stretches ahead, people who live
that future will be able to look back at an ever-lengthening history of
development, achievement and making a difference.
Happy Birthday BPL.
and thawing under controlled conditions, and extracting the clotting
factors from the thawed material. Following purification and
concentration, the finished bulk solutions are sterile filtered and
aseptically filled.
After the clotting factors have been separated, the remaining liquid
is bulked in large capacity vessels and centrifuged in sub-zero
conditions. Proteins are separated by the addition of ethanol and
other reagents. The precipitates are further processed to remove
residual alcohol and processed as albumins or immunoglobulins.
These products are also sterile filtered and aseptically filled.
During processing a number of quality checks are performed by
BPLs Quality Assurance and Quality Control departments.
BPL
During the 1940s, Brinkhous and McFarlane discovered that
transfusions using whole blood or plasma provided a means of FVIII
replacement. Applications using this early discovery were limited
due to naturally low concentrations of this anti-haemophilic factor in The Early Years
blood and plasma and volume constraints in the circulatory system.
Work in the development of blood products continued. In the
During this time, Professor R. A. Kekwick, working at the Lister
1950s, Kekwickdeveloped a method of fractionating out a
Institute undertook experimental and production work with A.S.
fibrinogen fraction rich in Factor VIII, the anti-haemophilic globulin.
McFarlane. The two scientists devised a process to clarify outdated
This led to the first clinical use of Factor VIII in treating haemophilia
blood plasma to render it suitable for transfusion2.
in 1957 and the need for large scale plasma fractionation, which
In 1943, Kekwick was appointed Head of the Lister s Biophysics BPL provided5.
In 1978, the Lister Institute sold the entire Elstree site to the
Division, Kekwick established the Blood Filtration Unit and he and
Lister Institute of his team worked on methods of freeze-drying plasma and then of
In 1959, a group led by Pool discovered that cryoprecipitate - the Government. As a result, the distinction of the scientists and
Preventative Medicine 1
separating out proteins in blood plasma. These early products were
cold, insoluble globulin precipitate formed during the slow thawing technicians dining in separate canteens was ended as BPL took
of plasma — contained a five-fold higher concentration of FVIII sole occupancy of the site. The average wage for a laboratory
In 1902 Dagger Farm in Aldenham, Hertfordshire, was sold to the used to meet the needs of the Armed Services and civilian compared to that of plasma. technician at BPL was £25.67 per week6.
Lister Institute of Preventative Medicine. It was located along the establishments.
By 1964, it was shown that cryoprecipitate could be separated by The running of BPL was transferred to the North West Thames
appropriately called Dagger Lane, where a nineteenth century In 1948 the Blood Filtration Unit came under the joint management
centrifugation and stored frozen. Because cryoprecipitate contained Regional Health Authority as an interim measure. In 1982 a Special
murder by stabbing had infamously occurred. of the Medical Research Council (MRC) and the Lister Institute, and
other proteins, such as fibrinogen, albumin and immunoglobulins, Health Authority was created called the Central Blood Laboratories
Joseph Lister had established his world famous Institute in 1891 to the name was changed to the Blood Products Research Unit. It
these needed to be extracted through the process of fractionation Authority (CBLA). Which administered BPL, PFL, Biomedical
undertake scientific research into the causes, prevention and occupied the newly built laboratories (or Building 25 ) and its aim
using ethanol. The use of fractionation had been developed by the Services and the Bristol based International Blood Group Reference
treatment of disease and to prepare and supply protective and was directed towards the preparation of plasma fractions for clinical
American Doctor Edwin Cohn in the 1940s. Laboratory (IBGRL) for approximately ten years.
curative materials such as vaccines and antitoxins. use3.
Fractionation also allowed the amount of Factor VIII to be PFL
The 35 acre Elstree site was used to house various farm animals concentrated to over 400 times the natural concentration found in In 1967 the Plasma Fractionation Laboratory (PFL) opened in
which were used to develop life saving vaccines for the treatment of blood plasma. By the late 1960s the process of freeze-drying Oxford (at the Churchill Hospital, Headington). Staffed by a small
then serious illnesses like diphtheria and scarlet fever. Queensbury (lyophilisation) was used to produce, concentrate and preserve number of people, PFL was established as BPLs pilot plant and to
Lodge, built in 1886 and currently BPLs administration centre, was Factor VIII products. produce special products for the treatment of rare forms of
the location of the research laboratories. haemophilia. The Oxford laboratories were a highly innovative
Some of the other proteins extracted through fractionation could be
A number of eminent scientists worked at the Lister Institute research centre - developing the first heat treatment process for
developed into different blood products. The first major non-
including Harden (the discoverer of co-enzymes) and the Factors VIII and IX in the mid-1980s - until their closure in 1992
coagulation factor to be developed was the Anti-D immunoglobulin
In 1954, the Government wished to establish a site for increased when all operations and staff were transferred to BPL.
microbiologist MacConkey. for treating rhesus-negative mothers.
production of blood products. This followed on from the importance
In 1954, the Lister Institute shared the Elstree site with the newly of blood in therapeutic medicine, the need for blood products BPLD
formed Blood Products Laboratory . In 1978, due to financial during the Second World War (particularly the use of albumin4) and The Blood Products Laboratory Diagnostics (BPLD) operation was
pressures and a decline in the demand for smallpox vaccines, the the formation on 26th September 1946 of the National Blood established in 1986 with the aim to provide a service for blood
Lister Institute was forced to leave due to financial problems and BPL Transfusion Service. It had also been discovered that a second grouping tests, for the identification of correct blood groups of
took sole control of the site. form of haemophilia (Haemophilia B) existed, which was treatable donors and patients, and diagnostic kits, such as screening cells,
with blood protein called Factor IX. for various blood centres and hospitals.
An agreement was reached between the Government, MRC and Closed in 1995, BPLD its operations were transferred to different
the Lister Institute and the Blood Products Laboratory was centres within the blood transfusion service.
established with funding from the Ministry of Health. Enlarged
facilities for plasma fractionation and freeze-drying were
established.

l. ns e. d. s. ns . ry ed
na ed sit en ns to ity
tio pe e pe pe pe ra un sh
uc )o tre lo op o
)o bli
54 era 64 trod 67 L 68 ce
d 78 Els
85 ve 86 s 87 7) 90 1 90 abo 91 m 98 ta 04
19 op 19 in 19 PF 19 odu 19 19 X de 19 ostic 19 ing 2 19 2 19 L 19 Im 19 t es 20 ay
es te y( rt th
e I n din
g
uc
ts
ow
n
ke d
or in of or ag ild
uil ar To
co
m
ipi
ta at ct Di Bu od Cr
e c bo
r
ti-
D
pier Fa ts y( t (B Pr ed alM BP
L
)b pr
e
La An cu d uc to
r
en Bi
o er n
PL an nd er
yo ion oc od fac rtm to Int
ry
(B Cr at le 8Y
) Pr w a e r re S
ion so II ( d Ne ep m Su
ra
to t e VI oo ld na NH
bo ac th r Bl ica of
a Fr is ct
o n
ge
L a PL Fa ch
ts m Te an
uc as .B ed Ch
od Pl ses at
Pr clo t tre
d te a
oo He
Bl titu
r Ins
te
Lis