How do you address viral, TSE and microbiological safety of platelet lysate? Are the donors screened prior to use?
Our platelet lysates are manufactured using expired apheresis platelet units sourced from AABB-accredited and FDA-registered blood centers. Donors provide the units voluntarily and are not reimbursed for their units. The platelet units are qualified according to FDA and AABB requirements for platelets for transfusion, including appropriate donor screening and testing for relevant communicable diseases according to 21 CFR 606, 21 CFR 610, 21 CFR 640, and relevant guidance. Cook Regentec maintains records supporting this documentation. TSE Statements, Certificate of Compliance, and animal derived statements are available for Stemulate.