INDONESIAN EXPERIENCE IN PRODUCING MINIPOOL CRYOPRECIPITATE. Yuyun SM Soedarmono

Transcription

1 INDONESIAN EXPERIENCE IN PRODUCING MINIPOOL CRYOPRECIPITATE Yuyun SM Soedarmono 1

2 BACKGROUND Indonesia has more than 240 million population and approximately 25,000 hemophilia A patients Hemophilia A patients have no optimal access to treatment and maintenance therapy Plasma fractionation is not done in Indonesia Commercial FVIII concentrates are costly and in limited supply Hemophilia A treatment mostly relies on cryoprecipitate without pathogen/bacteria removal nor pathogen/virus inactivation 2

3 BLOOD SERVICE IN INDONESIA Total Donation of 207 IRC BCs (2013): 2,4 million bags (83% from VNRD) 3,2 million bags of blood components fulfill +70% of blood needs 41 IRC-BCs in Sumatera island 13% Total donation 20 IRC-BCs in Kalimantan island 5% Total donation 20 IRC-BCs in Sulawesi island 4% Total donation 8 IRC-BCs in Maluku & Papua islands 1% Total donation 100 IRC-BCs in Java 75% Total donation 15 IRC-BCs in Bali, NTB,NTT islands 3% Total donation 3

4 THE NEED OF F VIII IU / patient / year For 25,000 patients with hemophilia A, the need of FVIII : IU / year Equal to 12,500,000 bags of cryoprecipitate ( IU FVIII /bag of cryoprecipitate) Currently, only limited cryoprecipitate has been produced due to various technical limitations ( facilities, freezing/centrifugation capacity, etc.) 4

5 CURRENT PRODUCTION OF CRYOPRECIPITATE WB PRC + PLASMA FFP CRYOPRECIPITATE 5

6 OBSTACLES IN PRODUCING CRYOPRECIPITATE IN INDONESIA Cryoprecipitate is produced from 350 ml WB Plasma was frozen in > 6 hours after phlebotomy Freezing mechanism mostly used -80 C deep freezers or blast freezers with temperature < C Plasma completely frozen within minutes Variable F VIII content 6

7 BLOOD SAFETY All blood collected was tested for: ABO and rhesus blood grouping Anti-HIV, HBsAg, Anti-HCV and TPHA using CHLIA or EIA method Only 5% followed by individual NAT in 8 big blood centres in Java No Anti-A or Anti-B antibody screening 7

8 MINIPOOL CRYOPRECIPITATE PRODUCTION Objective: To obtain qualified, safer and cost-efficient cryoprecipitate product Technique: Mini-Pool Cryoprecipitate using VIPS Kit (introduced by Egyptian Company for Biological Sciences / ECBS Cairo) Procedure: bags of cryoprecipitate were pooled in the SD treatment bag to inactivate any lipid-enveloped viruses, followed by filtration to remove any bacterial contamination 8

9 VIPS MINIPOOL CRYO KIT 9

10 TRAINING ON MINIPOOL CRYO PRODUCTION 10

11 FIRST TRIAL OF MINIPOOL CRYO PRODUCTION 40 bags of cryoprecipitate were pooled in VIPS Kit following the manufacturer s instructions Not initially satisfied by the quality of final cryoprecipitate product: F VIII content : 5.56 IU/ml Clottable fibrinogen content : g/l Low titer of F VIII and fibrinogen could be due to: FFP produced from 350 ml WB Plasma frozen in > 6 hour after phlebotomy and complete freezing in > 1 hour Inappropriate cryoprecipitate thawing 11

12 SECOND TRIAL OF MINIPOOL CRYO PRODUCTION We improved our blood collection and FFP processing: Blood collection using 450 ml triple bag FFP processing was run < 6 hours after phlebotomy Complete plasma freezing within 40 minutes using Contact Freezer with C temperature FFP was stored < 5 days at C temperature Cold thawing of FFP at 1 6 C overnight, followed by hard spin centrifugation at 1 4 C Pooling of cryoprecipitate was run on the same day as cryoprecipitate production 12

13 RESULTS OF THE SECOND TRIAL Better quality of final cryoprecipitate product: F VIII content : 7,52 IU/ml Clottable fibrinogen content : 34,91 g/l 13

14 FUTURE PLAN Introducing 450 ml WB collection Maintaining FFP processing < 6 hours after phlebotomy, followed by complete freezing in < 1 hour Running mini pool cryoprecipitate production to meet the needs Follow up the clinical risk of mini pool cryoprecipitate products usage Implementing antibody screening on blood that will be processed into cryoprecipitate 14

15 CONCLUSION Mini pool cryoprecipitate product has stable content of F VIII and clottable fibrinogen, and lower risk of viral and bacterial contamination Improvement of blood collection, FFP & cryoprecipitate production and storage are keys to get qualified mini pool cryoprecipitate product Mini pool cryoprecipitate product can improve the management of hemophilia A patients in Indonesia 15

16 THANK YOU 16