History Of Plasma

The History and Development of The History and Development of Plasma-Derived ProductsPlasma-Derived Products

The BPL ExperienceThe BPL Experience

Dr Clive DashDr Clive Dash

Medical Director Medical Director

BPL, ElstreeBPL, Elstree

A Century of TraditionA Century of Tradition

The British Institute of The British Institute of Preventive MedicinePreventive Medicine

• 18911891• Merged with College of State MedicineMerged with College of State Medicine• CharitableCharitable• Not for profitNot for profit

101 Great Russell Street101 Great Russell Street

Four Main AimsFour Main Aims

• Undertake Undertake fundamental fundamental scientific research scientific research into causes, into causes, prevention and prevention and treatment of diseasetreatment of disease

• Teach preventive Teach preventive medicinemedicine

• Prepare and supply Prepare and supply special protective special protective and curative and curative materials, materials, e.g.e.g. vaccines and vaccines and antitoxinsantitoxins

• Treat persons with Treat persons with infective diseasesinfective diseases

Lister Institute - ChelseaLister Institute - Chelsea

The First DecadeThe First Decade

• Great Russell Street and SudburyGreat Russell Street and Sudbury• 1898:1898: Jenner Institute of Preventive Jenner Institute of Preventive

MedicineMedicine

Moved to Chelsea Moved to Chelsea • Lister Institute of Preventive MedicineLister Institute of Preventive Medicine• 1902:1902: Elstree site replaced SudburyElstree site replaced Sudbury

Queensbury Lodge - ElstreeQueensbury Lodge - Elstree

The First 50 YearsThe First 50 Years

• Therapeutic IgGs from seraTherapeutic IgGs from sera

- Reactions- Reactions• Smallpox vaccines (in 1952, WHO Smallpox vaccines (in 1952, WHO

regarded it as the best FD preparation)regarded it as the best FD preparation)

- Worldwide eradication- Worldwide eradication• Bacterial vaccinesBacterial vaccines

- Antibiotics- Antibiotics

The Decade of ChangeThe Decade of Change

19421942• Blood Products Research Unit formed at Blood Products Research Unit formed at

ChelseaChelsea

• Freeze-dried plasma produced with Freeze-dried plasma produced with cooperation of Medical Research Council cooperation of Medical Research Council at Cambridgeat Cambridge

Cooperative ResearchCooperative Researchintointo

Blood ProductsBlood Products

• Biophysics Dept Biophysics Dept of:of:

Lister Institute of Lister Institute of Preventive Preventive MedicineMedicine

• Blood Products Blood Products Research Unit of:Research Unit of:

Medical Research Medical Research Council (MRC)Council (MRC)

The Last 50 YearsThe Last 50 Years

19531953• Factor VIII assay developed at OxfordFactor VIII assay developed at Oxford• Produced FVIII from bovine bloodProduced FVIII from bovine blood• Blood Products Laboratory established at Blood Products Laboratory established at

Elstree by HM Government (cost £175,000) Elstree by HM Government (cost £175,000) to be run by MRC to be run by MRC

• On behalf of MoH to supply human blood On behalf of MoH to supply human blood products for the NHSproducts for the NHS

The Last 50 YearsThe Last 50 Years

• Blood Group Research at Elstree (IBGRL)Blood Group Research at Elstree (IBGRL)• 1963:1963: Trachoma vaccineTrachoma vaccine

Anti-DAnti-D• ThrombinThrombin FibrinogenFibrinogen

Gamma-globulinGamma-globulin PPFPPF

Anti-haemophilicAnti-haemophilic• 1978:1978: Lister Institute closes Lister Institute closes

BPL occupies whole site at ElstreeBPL occupies whole site at Elstree

Elstree Estate - 1966Elstree Estate - 1966

The Last 50 YearsThe Last 50 Years

• 1985:1985: Terminal heat treatment of Terminal heat treatment of FVIII / IX (80FVIII / IX (8000C for 72 hours)C for 72 hours)

• 1987:1987: New production facility (£60M)New production facility (£60M)

Funded by DoHFunded by DoH• 1990:1990: Renamed -Renamed -

Bio Products Laboratory (BPL)Bio Products Laboratory (BPL)

BPL Production - ElstreeBPL Production - Elstree

The End of the MillenniumThe End of the Millennium

Current ProductsCurrent ProductsFVIII + vWPFVIII + vWP Vigam-SVigam-S Zenalb 20Zenalb 20

FVIIIFVIII Vigam LiquidVigam Liquid Zenalb 4.5Zenalb 4.5

FIXFIX Anti-DAnti-D

(FXI)(FXI) IM IgGs:IM IgGs:

(FXIII)(FXIII) VZVVZV

(FVII)(FVII) HepBHepB (IVHepB)(IVHepB)

(ATIII)(ATIII) TetanusTetanus

RabiesRabies

The End of the MillenniumThe End of the Millennium

Research ProjectsResearch Projects

FVIII / vWPFVIII / vWP

FVIII / IX including CIFVIII / IX including CI

Fibrin SealantFibrin Sealant

AlphaAlpha11 Acid Glycoprotein (AAG) Acid Glycoprotein (AAG)

Subcutaneous IgGSubcutaneous IgG

Monoclonal anti-DMonoclonal anti-D

The Beginning of a ChangeThe Beginning of a Change

• 1996:1996: nvCJD identified by CJD nvCJD identified by CJD Surveillance Unit (Edinburgh)Surveillance Unit (Edinburgh)

• Oct/Nov ‘97:Oct/Nov ‘97: 3 known donors = product 3 known donors = product recallsrecalls

• Oct/Nov ‘97:Oct/Nov ‘97: DoH set up risk assessment DoH set up risk assessment

Secretary of State for HealthSecretary of State for Health

“ “We have no evidence to show that We have no evidence to show that nvCJD can be transmitted nvCJD can be transmitted viavia blood or blood or blood products - the risk remains blood products - the risk remains hypothetical. hypothetical.

But we must proceed on the principle But we must proceed on the principle that it is better to be safe than sorry.”that it is better to be safe than sorry.”

Frank DobsonFrank Dobson 26 Feb 199826 Feb 1998

DoH StatementDoH Statement26 Feb ‘9826 Feb ‘98

(a)(a) Committee for Safety of Medicines Committee for Safety of Medicines (CSM) to review plasma products(CSM) to review plasma products

(b)(b) BPL to BPL to identifyidentify non-UK plasma non-UK plasma

sourcessources

(c)(c) Anxiety about recalls & blood supplyAnxiety about recalls & blood supply

CSM review of blood productsCSM review of blood products 13 May 199813 May 1998

“ “The reasons for moving to non-UK The reasons for moving to non-UK sourced plasma for the time being are sourced plasma for the time being are that, although there is currently no that, although there is currently no evidence that nvCJD can be transmitted evidence that nvCJD can be transmitted by blood, there is still a theoretical risk.”by blood, there is still a theoretical risk.”

DoH press releaseDoH press release

Precautionary measuresPrecautionary measureswhy?why?

• nvCJD risk theoretical - hard to quantifynvCJD risk theoretical - hard to quantify• balancing product availability and hypothetical balancing product availability and hypothetical

risk of transmissibilityrisk of transmissibility• CSM: blood product recalls to include CSM: blood product recalls to include

“strongly suspected” cases of nvCJD“strongly suspected” cases of nvCJD• potential for further recalls may undermine potential for further recalls may undermine

public confidencepublic confidence• manufacturing process may remove prion - manufacturing process may remove prion -

impossible to validateimpossible to validate

CSM review of blood productsCSM review of blood products 13 May 199813 May 1998

DoH press releaseDoH press release • ““The NHS Bio Products Laboratory ……. The NHS Bio Products Laboratory …….

have been advised to take steps to source have been advised to take steps to source products from plasma derived from products from plasma derived from outside the UK, while giving due regard to outside the UK, while giving due regard to the supply of vital products to patients”the supply of vital products to patients”

BPL SummaryBPL Summary

• Basis as ‘not for profit’ since 19th CBasis as ‘not for profit’ since 19th C• Research tradition (Lister, MRC, WHO)Research tradition (Lister, MRC, WHO)• Wide range of productsWide range of products• Continuing product improvementsContinuing product improvements• Facility updates: Facility updates:

capital projectscapital projects and trainingand training• Government supportedGovernment supported• Government supportGovernment support