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History Of Plasma


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Plasma and blood products: a medical history

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History Of Plasma

  1. 1. The History and Development of Plasma-Derived Products The BPL Experience Dr Clive Dash Medical Director BPL, Elstree
  2. 2. A Century of Tradition
  3. 3. The British Institute of Preventive Medicine <ul><li>1891 </li></ul><ul><li>Merged with College of State Medicine </li></ul><ul><li>Charitable </li></ul><ul><li>Not for profit </li></ul>
  4. 4. 101 Great Russell Street
  5. 5. Four Main Aims <ul><li>Undertake fundamental scientific research into causes, prevention and treatment of disease </li></ul><ul><li>Teach preventive medicine </li></ul><ul><li>Prepare and supply special protective and curative materials, e.g. vaccines and antitoxins </li></ul><ul><li>Treat persons with infective diseases </li></ul>
  6. 6. Lister Institute - Chelsea
  7. 7. The First Decade <ul><li>Great Russell Street and Sudbury </li></ul><ul><li>1898: Jenner Institute of Preventive Medicine </li></ul><ul><li>Moved to Chelsea </li></ul><ul><li>Lister Institute of Preventive Medicine </li></ul><ul><li>1902: Elstree site replaced Sudbury </li></ul>
  8. 8. Queensbury Lodge - Elstree
  9. 9. The First 50 Years <ul><li>Therapeutic IgGs from sera </li></ul><ul><li>- Reactions </li></ul><ul><li>Smallpox vaccines (in 1952, WHO regarded it as the best FD preparation) </li></ul><ul><li>- Worldwide eradication </li></ul><ul><li>Bacterial vaccines </li></ul><ul><li>- Antibiotics </li></ul>
  10. 10. The Decade of Change <ul><li>1942 </li></ul><ul><li>Blood Products Research Unit formed at Chelsea </li></ul><ul><li>Freeze-dried plasma produced with cooperation of Medical Research Council at Cambridge </li></ul>
  11. 11. Cooperative Research into Blood Products <ul><li>Biophysics Dept of: </li></ul><ul><li>Lister Institute of Preventive Medicine </li></ul><ul><li>Blood Products Research Unit of: </li></ul><ul><li>Medical Research Council (MRC) </li></ul>
  12. 12. The Last 50 Years <ul><li>1953 </li></ul><ul><li>Factor VIII assay developed at Oxford </li></ul><ul><li>Produced FVIII from bovine blood </li></ul><ul><li>Blood Products Laboratory established at Elstree by HM Government (cost £175,000) to be run by MRC </li></ul><ul><li>On behalf of MoH to supply human blood products for the NHS </li></ul>
  13. 13. The Last 50 Years <ul><li>Blood Group Research at Elstree (IBGRL) </li></ul><ul><li>1963: Trachoma vaccine </li></ul><ul><li>Anti-D </li></ul><ul><li>Thrombin Fibrinogen </li></ul><ul><li>Gamma-globulin PPF </li></ul><ul><li>Anti-haemophilic </li></ul><ul><li>1978: Lister Institute closes </li></ul><ul><li>BPL occupies whole site at Elstree </li></ul>
  14. 14. Elstree Estate - 1966
  15. 15. The Last 50 Years <ul><li>1985: Terminal heat treatment of FVIII / IX (80 0 C for 72 hours) </li></ul><ul><li>1987: New production facility (£60M) </li></ul><ul><li>Funded by DoH </li></ul><ul><li>1990: Renamed - </li></ul><ul><li>Bio Products Laboratory (BPL) </li></ul>
  16. 16. BPL Production - Elstree
  17. 17. The End of the Millennium <ul><li>Current Products </li></ul><ul><li>FVIII + vWP Vigam-S Zenalb 20 </li></ul><ul><li>FVIII Vigam Liquid Zenalb 4.5 </li></ul><ul><li>FIX Anti-D </li></ul><ul><li>(FXI) IM IgGs: </li></ul><ul><li>(FXIII) VZV </li></ul><ul><li>(FVII) HepB (IVHepB) </li></ul><ul><li>(ATIII) Tetanus </li></ul><ul><li>Rabies </li></ul>
  18. 18. The End of the Millennium <ul><li>Research Projects </li></ul><ul><li>FVIII / vWP </li></ul><ul><li>FVIII / IX including CI </li></ul><ul><li>Fibrin Sealant </li></ul><ul><li>Alpha 1 Acid Glycoprotein (AAG) </li></ul><ul><li>Subcutaneous IgG </li></ul><ul><li>Monoclonal anti-D </li></ul>
  19. 19. The Beginning of a Change <ul><li>1996: nvCJD identified by CJD Surveillance Unit (Edinburgh) </li></ul><ul><li>Oct/Nov ‘97: 3 known donors = product recalls </li></ul><ul><li>Oct/Nov ‘97: DoH set up risk assessment </li></ul>
  20. 20. Secretary of State for Health <ul><li>“ We have no evidence to show that nvCJD can be transmitted via blood or blood products - the risk remains hypothetical. </li></ul><ul><li>But we must proceed on the principle that it is better to be safe than sorry.” </li></ul><ul><li>Frank Dobson </li></ul><ul><li> 26 Feb 1998 </li></ul>
  21. 21. DoH Statement 26 Feb ‘98 <ul><li>(a) Committee for Safety of Medicines (CSM) to review plasma products </li></ul><ul><li>(b) BPL to identify non-UK plasma </li></ul><ul><li>sources </li></ul><ul><li>(c) Anxiety about recalls & blood supply </li></ul>
  22. 22. CSM review of blood products 13 May 1998 <ul><li>“ The reasons for moving to non-UK sourced plasma for the time being are that, although there is currently no evidence that nvCJD can be transmitted by blood, there is still a theoretical risk.” </li></ul><ul><li>DoH press release </li></ul>
  23. 23. Precautionary measures why? <ul><li>nvCJD risk theoretical - hard to quantify </li></ul><ul><li>balancing product availability and hypothetical risk of transmissibility </li></ul><ul><li>CSM: blood product recalls to include “strongly suspected” cases of nvCJD </li></ul><ul><li>potential for further recalls may undermine public confidence </li></ul><ul><li>manufacturing process may remove prion - impossible to validate </li></ul>
  24. 24. CSM review of blood products 13 May 1998 <ul><li>DoH press release </li></ul><ul><li>“ The NHS Bio Products Laboratory ……. have been advised to take steps to source products from plasma derived from outside the UK, while giving due regard to the supply of vital products to patients” </li></ul>
  25. 25. BPL Summary <ul><li>Basis as ‘not for profit’ since 19th C </li></ul><ul><li>Research tradition (Lister, MRC, WHO) </li></ul><ul><li>Wide range of products </li></ul><ul><li>Continuing product improvements </li></ul><ul><li>Facility updates: </li></ul><ul><li>capital projects and training </li></ul><ul><li>Government supported </li></ul><ul><li>Government support </li></ul>