wfh bangkok 2004 self-sufficiency of plasma derivatives
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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 toleranceSurgical 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: 93-100
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