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Self-Sufficiency of Plasma Derivatives

Self-Sufficiency of Plasma Derivatives. Definition. The provision of human blood and plasma products from within a certain population to satisfy the clinical needs of that population. History & Rationale. Council of Europe. Recommendation R (88) 4, March 1988 :

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Self-Sufficiency of Plasma Derivatives

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  1. Self-Sufficiency of Plasma Derivatives

  2. Definition • The provision of human blood and plasma products from within a certain population to satisfy the clinical needs of that population

  3. History & Rationale • Council of Europe. Recommendation R (88) 4, March 1988 : • Every country should aim at self-sufficiency in the supply and distribution of blood over its entire territory • “ Self-sufficiency with respect to blood products is one of the basic conditions for minimising the hazard of the transmission of infectious disease by blood transfusion”

  4. Other Advantages • Improved utilisation of national resources • Prevention of “virus tourism” • Represents relevant local antibody content • Cost reduction opportunity • Increased availability of products • Equality of treatment • Avoids introduction of sub-optimal products

  5. Prerequisites • National commitment • Selection of a fractionation partner with experience in the development, administration and logistics of self-sufficiency projects

  6. Attaining Self-Sufficiency • Degree & cost-savings of self-sufficiency based on: • Careful selection of fractionation partner • Safe & reliable project administration • Variable and small batch sizes • Safe, reliable and consistent production • State-of-the-art products • High yields

  7. Selection of Fractionation Partner • Proven experience of managing self-sufficiency projects • Fractionation capacity • International & local reputation • Solid financial background • Reliable local representation

  8. Safe & Reliable Project Administration • Established history of self-sufficiency ability • “Total package” administration: • Donor centre auditing donor recruitment programmes • Educational support staff training • Distribution transportation logistics • Trust & transparency • Pro-active problem-solving approach • Ongoing commitment to evaluation & improvement

  9. Variable Production Scales • Ability to offer both regional and national self-sufficiency requires: • Production flexibility • Variable batch size • Short production & delivery schedules • Commitment to safety

  10. Safe, Reliable, Consistent Production • GMP: Good Manufacturing Practice • Batch-to-batch consistency • Attainment & maintenance of international standards • Independent batch release by recognised international laboratories

  11. State-of-the-Art Products • Worldwide registrations • Double virus inactivation • Purification methods • Ongoing R&D programme • Product / portfolio enhancement option included in contract

  12. High Yields • Maximum utilisation of valuable national resource • Increased availability of products • More patients access treatment • Expansion of clinical indications • Improved treatment regimens • Prophylaxis • Immune tolerance • Surgical procedures • Optimised costs

  13. State-of-the-Art Facilities • Separation of product, material, personnel and waste flows • Validation of processes, analytical methods and equipment • Clean areas according to the production steps • Training of the employees • Efficient technology

  14. Dedicated to Self-Sufficiency • Size of the fractionation batches • Dedicated equipment according to plasma origin • Fractionation equipment with CIP and SIP • Autonomy for the whole process, from plasma to final product

  15. Octapharma & Self-Sufficiency • Octapharma products have significantly improved the quality of life for thousands of patients in Norway during the last 15 years • Around 200 haemophiliacs are treated with Octapharma products every year • Waiting-lists for elective surgery in haemophiliacs have disappeared • The haemophilia treatment regimen has now reached a level of high European standard • Emergency stock of plasma products increased from zero to six months • Flesland O et al. The Norwegian plasma fractionation project: A 12 year clinical & economic success story. Transfusion & Apheresis Science 2003; 28: 93-100

  16. Octapharma Self-Sufficiency Experience • More than 15 years experience with self-sufficiency programmes • Austria • Belgium • Brazil • Germany • Norway • Slovenia • France • Netherlands, etc

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