WFH Bangkok 2004 Self-Sufficiency of Plasma Derivatives

WFH Bangkok 2004 Definition The provision of human blood and plasma products from within a certain population to satisfy the clinical needs of that population

WFH Bangkok 2004 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”

WFH Bangkok 2004 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

WFH Bangkok 2004 Prerequisites National commitment Selection of a fractionation partner with experience in the development, administration and logistics of self-sufficiency projects

WFH Bangkok 2004 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

WFH Bangkok 2004 Selection of Fractionation Partner Proven experience of managing self-sufficiency projects Fractionation capacity International & local reputation Solid financial background Reliable local representation

WFH Bangkok 2004 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

WFH Bangkok 2004 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

WFH Bangkok 2004 Safe, Reliable, Consistent Production GMP: Good Manufacturing Practice Batch-to-batch consistency Attainment & maintenance of international standards –Independent batch release by recognised international laboratories

WFH Bangkok 2004 State-of-the-Art Products Worldwide registrations Double virus inactivation Purification methods Ongoing R&D programme Product / portfolio enhancement option included in contract

WFH Bangkok 2004 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

WFH Bangkok 2004 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

WFH Bangkok 2004 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

WFH Bangkok 2004 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:

WFH Bangkok 2004 Octapharma Self-Sufficiency Experience More than 15 years experience with self- sufficiency programmes –Austria –Belgium –Brazil –Germany –Norway –Slovenia –France –Netherlands, etc