Evolution of the role of Finnish Red Cross Blood Service in the national plasma product program

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1 Evolution of the role of Finnish Red Cross Blood Service in the national plasma product program IPFA/PEI 20th International Workshop on surveillance and screening of blood borne pathogens Helsinki April 2013 Martti Syrjälä 1

2 Prof. Harri Nevanlinna Prof. Juhani Leikola Prof. Gunnar Myllylä Prof. Jukka Koistinen

3 2012 key figures Blood Service in Brief 540 employees 18 permanent locations and mobile services A non-profit organisation 66 million euros in turnover 143, ,000 50,000 donors > blood donations > patients We create potential for saving lives Blood components to hospitals Clinical laboratory services Antenatal blood group determination Tissue compatibility tests Stem cell transplants Tissue services Pharmaceutical distribution Research and development

4 FRCBS locations 18 donor centres blood collection Blood Service Centre Helsinki collection, production, distribution testing other FRSBS operations Mobile blood service Helsinki, Oulu, Kuopio, Tampere, Turku, Seinäjoki over 1000 sessions yearly around the country Vaasa Pori Turku Kokkola Seinäjoki Tampere Hämeenlinna Espoo Oulu Kuopio Jyväskylä Rovaniemi Mikkeli Lappeenranta Lahti 4 Helsinki Joensuu

5 Milestones in the national plasma product program The Boy Scout Blood Union is founded 1940 The Defence Forces organises blood collections during the war 1950 FRC BS is founded Freeze-dried plasma (in cooperation with Orion Ltd) Fresh frozen plasma for haemophilia patients Albumin and gammaglobulin fractionation (State Serum Institute)

6 Number of blood donations in Finland in

7 Milestones 1960 Contract manufacturing (albumin and gammaglobulin): Kabi AB, Swiss Red Cross, Dutch Red Cross) Cryo-AHG frozen plasma 1970 Lyophilized Cryo-AHG (pools of 2 or 8 units) First Cohn fractionation unit in FRC BS (with the help of Swiss and Dutch Red Cross) 1980 Second Cohn fractionation unit in FRC BTS Intermediate purity, heat inactivated FVIII concentrate. HIV safe, heat treated Cryo-AHG was introduced in High purity SD-treated FVIII product (under a licence from Baxter. Virus safe IvIg

8 Planning of the plant (Presented by Dr. Myllylä in the Seminar on National Self-reliance in Blood and Blood Fractions for Developing Countries, Stockholm )

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10 Costs of the 2nd fractionation unit

11 Milestones 2000 FRC BS market share albumin 100 % FIX 100 % FVIII 80 % iv-immunoglobulins 70 % im-immunoglobulins 100 % Closing of the FRC BS fractionation plant in Helsinki Contract manufacturing from Finnish plasma: Sanguin Octapharma 2010 Sales of plasma collected in Finland Baxter Octapharma

12 Products and donations Whole blood RBC Platelets FFP Donations

13 HIV infections transmitted by blood or plasma components in Finland 2/220 haemophilia patients transmitted 6 other patients transmitted by blood components all transmissions No transmissions transmission rate (< 1 % of haemofiliacs) was one of the lowest in the developed countries. Two main reasons: low incidence of HIV in the donor population small pool FVIII product

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15 Estimated residual risk of infectious donation in Finland in HBV HCV HIV Residual risk - per million donations donations per infectious 625,000 25,000,000 25,000,000 donation Data are given for all donors as weighted average of first time and repeat blood donors

16 Annual number of HIV-, HBV-, HCV- ja syphilis infections in blood donors in Finland in HIV/yr HBV/yr HCV/yr Syphilis/yr Donations/yr Tom Krusius 25 February

17 Finnish Red Cross Blood Service Aim during the first six decades: National self-sufficiency of whole blood, blood products, plasma and plasma derived drugs. Now: National self-sufficiency of plasma and plasma derived drugs is not an issue any more. It has turned to European selfsufficiency