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In the name of Allah

In the name of Allah. Dr. H. Abolghasemi Managing Director Iranian Blood Transfusion Organization. Plasma for Fractionation IRAN Experience. Annual need for blood products is increasing Marketing research Bureau 2006-2007 Clotting factors IVIg Albumin

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In the name of Allah

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  1. In the name of Allah XXXth International congress of ISBT, June 7-12, 2008, Macao

  2. Dr. H. AbolghasemiManaging Director Iranian Blood Transfusion Organization Plasma for Fractionation IRAN Experience XXXth International congress of ISBT, June 7-12, 2008, Macao

  3. Annual need for blood products is increasing Marketing research Bureau 2006-2007 Clotting factors IVIg Albumin Average annual growth rate of factor VIII, factor IX, AAT, fibrin sealant, IVIg, and albumin being 3%,1.9%,13%,3.4%,6-8% , 2% respectively. Product demand XXXth International congress of ISBT, June 7-12, 2008, Macao

  4. Worldwide plasma market including recombinant products Others US$ bn. MRB-Report: Feb 2005 Figures 2005 estimated XXXth International congress of ISBT, June 7-12, 2008, Macao 1

  5. Worldwide need of immunoglobulins CAGR 2004/10 = 6,5 % IVIG (tons) MRB-Report: Feb 2005 XXXth International congress of ISBT, June 7-12, 2008, Macao 2

  6. Why contract fractionation? • National blood services play crucial role in providing safe and adequate plasma to be fractionated to the very important medicine including clotting factors,albumin and immunoglobulines.Although importing these medicines might be a prompt aproach to furnish national market with these medicines, worldwide shortage of these medicines and limited resources available in countries health care system make this approach far from ideal XXXth International congress of ISBT, June 7-12, 2008, Macao

  7. Why contract fractionation? • An alternative would be either to produce these medicines locally or use contract fractionation approach in order to meet needs of local market • Due to its financial and technical requirements and considerations establishing a facility for local production at least in developing countries has not been fruitfful XXXth International congress of ISBT, June 7-12, 2008, Macao

  8. Cost-effectiveness because of Rich resource of blood donors in our country The number of plasma units in our blood centers being higher than the hospital demand rate. Decrease in import demand of blood products including IVIg and factor VIII. Why Contract Fractionation in IRAN? XXXth International congress of ISBT, June 7-12, 2008, Macao

  9. XXXth International congress of ISBT, June 7-12, 2008, Macao

  10. Iranian Blood TransfusionOrganization • Integral part of the national health system • Blood donation being voluntary and non-remunerated (100%) • Centralized. All blood centers throughout the country are under supervision of IBTO headquarters. All procedures, kits, and equipment are the same and follow a similar standard in all blood centers. All organizational policies mandated by the headquarters are issued to all centers. XXXth International congress of ISBT, June 7-12, 2008, Macao

  11. Ministry of Health BCC BCC BCC BTC BCC BCC BCC A Provincial Transfusion Center IBTO HEADQUARTERS BTC: Blood Transfusion Center BCC: Blood Collection Center XXXth International congress of ISBT, June 7-12, 2008, Macao

  12. Trend of Blood Donation in Iran (1974-2007) Units XXXth International congress of ISBT, June 7-12, 2008, Macao

  13. Trend of Yearly Donation Index in Iran(1974-2007) Per 1000 XXXth International congress of ISBT, June 7-12, 2008, Macao

  14. Trend of Transition to 100% Voluntary Blood Donation in Iran (1996-2007) Percent XXXth International congress of ISBT, June 7-12, 2008, Macao

  15. National Blood Program Donor Screening Blood Testing Q.C XXXth International congress of ISBT, June 7-12, 2008, Macao

  16. IBTO started to send the recovered plasma for fractionation to two fractionation facilities in Europe following the contract concluded in 2005. • End products are returned to our country. • Our goal is to have a safe and sufficient plasma derivatives to meet the majority of needs of our population in the country XXXth International congress of ISBT, June 7-12, 2008, Macao

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  19. Flow work for plasma shipment to fractionation center agreement of medicines regulatory Authority Assessment of the shipment volume Audit of the selected centers by an appointed official auditor from Europe Audit of the fractionation center by an Iranian auditor (appointed by supplier party and Health Minister) Approval of plasma contract for fractionation Licensing XXXth International congress of ISBT, June 7-12, 2008, Macao

  20. Quantity shipment of plasma can still raise because just 16 out of 30 blood transfusion centers across Iran have already been active contributing to contract fractionation. We have formulated and started to implement the program to increase the total number of blood centers eligible to send plasma Increase Quantity of Plasma Increase Total Number of Donations XXXth International congress of ISBT, June 7-12, 2008, Macao

  21. 3 kinds of products: 1) Haemoctin 2) Intratect 3) Human Albumin XXXth International congress of ISBT, June 7-12, 2008, Macao

  22. Plasma fractionation caused improvement in the system specially Documentation,take PCR sample and cold chain. More strict standards for plasma fractionation. Several external audits from certified body of Europe. pushing toward implimentation of automation in our system. Improvements in IBTO system XXXth International congress of ISBT, June 7-12, 2008, Macao

  23. Automation of lab tests and implementation of the new software XXXth International congress of ISBT, June 7-12, 2008, Macao

  24. Automation of lab tests XXXth International congress of ISBT, June 7-12, 2008, Macao

  25. Home made Blast freezers replaced mechanical freezing. The plasma core temperature reaches -30°c within less than 1 hour in blast freezer. XXXth International congress of ISBT, June 7-12, 2008, Macao

  26. Improvement of the cold rooms and freezing rooms • Freezer temperature shall be less than -25°C during the whole storage period. • Because we already have a contract with a European country, our freezing storage standards shall comply with European Pharmacopoeia. • The European Pharmacopoeia has a provision stating that if the temperature of the plasma is between -20°C and -15°C for a maximum of 72 hours, or if it is above -15°C (but colder than - 5°C) in no more than one occurrence, the plasma can still be used for fractionation. XXXth International congress of ISBT, June 7-12, 2008, Macao

  27. Look back Donor • Improvement of our look back system. • Every blood donor can be recalled if the follow up is necessary. • System is established to immediately notify fractionation center once a test is positive. Fractionation center XXXth International congress of ISBT, June 7-12, 2008, Macao

  28. Responsibilities and roles of blood establishmentwho expert committee 2007 • Collects and analyses the epidemiologic data and surveilance of donor population based on results of screening tests. • Develops and implements the criteria in selection and interview of donors. • Performs validated tests (or the tests maybe sub-contracted). • Hemovigilance:Informs plasma fractionator (and when appropriate the regulatory authority) when relevant information is obtained. • Collects blood plasma, prepares, freezes, and stores the plasma, according to good manufacturing practice (GMP). • Prepares the NAT samples following fractionators' specifications • Implements GMP. XXXth International congress of ISBT, June 7-12, 2008, Macao

  29. Responsibilities and roles of plasma fractionatorswho expert committee 2007 • Review the epidemiological data. • Verifies donor selection criteria set by national regulatory authority are met; may provide additional selection criteria. • Agrees on the tests kits used and audits the virology laboratory. • Hemovigilance: Takes appropriate measures if plasma pool or product quality is compromised. • Preparation of plasma : Sets the specifications and audits. • Provides the standard operating procedure for NAT samples and performs (or sub-contracts) the validated testing. • Applies the fractionation methods including viral inactivation following GMPs and processes described in marketing authorization. • Prepares of plasma product regulatory files • GMP : Audits the blood establishment. • Does pharmacovigilance studies and informs regulatory authorities and blood establishment when relevant side-effects are found. XXXth International congress of ISBT, June 7-12, 2008, Macao

  30. Responsibilities and roles of regulatory authoritieswho expert committee 2007 • Review the epidemiological data. • Sets the criteria and inspects the blood establishment. • Approves test kits and inspects the blood establishment. • Evaluates haemovigilance/post-donation reports with regards to product quality and safety. • Approves and inspects the blood establishment. • Approves the procedure and inspects the plasma fractionator. • Evaluates the data presented in the dossiers prepared by the fractionator, and inspects fractionation facility. • Reviews and evaluates regulatory files. • Inspects blood establishment and enforces GMP. • Grants the marketing authorization. • Evaluates pharmacovigilance reports with regards to product quality and safety. XXXth International congress of ISBT, June 7-12, 2008, Macao

  31. Notification obligation : • Deviation is subsequently discovered in any of screening tests performed on the plasma unites supplied • A regular donor is found to be positive for a marker although the previous donation was found negative. (starting look back procedure) • A donation is found to have transmitted an infectious disease potentialy transmissible by plasma. • We are informed that a donor previousely contributing to plasma for fractionation has developed an infectious disease potentially transmissible by plasma • Post transfusion infection following transfusion of blood components obtained from a donor who has also donated one or more unites of plasma for fractionation • A unit positive for viral markers has been sent by mistake XXXth International congress of ISBT, June 7-12, 2008, Macao

  32. Conclusion : Advantages of plasma fractionation contract in IRAN • Prevention of 200,000 liters of fresh frozen plasma to be wasted • 35% cost reduction of plasma derivatives and a reduction in products import with foreign resources • Prevention of patient exposure to foreign biological products and patient protection against unwanted infections • Standardization of plasma for fractionation leading to the improvement of all the procedures in preparation of blood components • Implementation of a look back system and tracing back based on the NAT results XXXth International congress of ISBT, June 7-12, 2008, Macao

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  34. Thank you XXXth International congress of ISBT, June 7-12, 2008, Macao

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