Plasma standards and protein yield.ppt

Plasma standards and protein yield Albert Farrugia Head, Blood Tissues Unit Australian Therapeutic Goods Administration Fourth World Federation of Hemophilia Global Forum on the safety and supply of treatment products for bleeding disorders Montreal, Canada - September 26-27 2005 Available standards Available standards The regulatory requirements underpinning blood and plasma storage, freezing and frozen storage are predicated on the needs of Factor VIII Is this justified? European plasma standardsFVIII levels Council of Europe (for transfusion) Requirement for 70% of the “average normal value” controlled through measurement of FVIIIc every two months on a pool of six units of mixed blood groups during the first and last months of storage European Pharmacopeia (for fractionation) On a pool of not fewer than ten units, measurement of factor VIII, using the EP reference method and a reference plasma calibrated against the International Standard for blood coagulation factor VIII in plasma. The activity is not less than 0.7 I.U. per millilitre. Factors claimed to affect FVIII yield in fractionated concentrates Anticoagulant Collection method Time/Temperature to separation/freezing Freezing rate Storage conditions of frozen plasma Thawing conditions Purification chemistry Viral inactivation Factors claimed to affect FVIII yield in fractionated concentrates Anticoagulant Collection method Time/Temperature to separation/freezing Freezing rate Storage conditions of frozen plasma Thawing conditions Purification chemistry Viral inactivation Source vs recovered plasma FVIII yield in low purity concentrates Factors claimed to affect FVIII yield in fractionated concentrates Anticoagulant Collection method Time/Temperature to separation/freezing Freezing rate Storage conditions of frozen plasma Thawing conditions Purification chemistry Viral inactivation Factor VIII content – Freezing rates and pack typesSmith et al (1985) Dev Hem Imm 13 :15-23 DOES IT MATTER? Ther