Ammonium-Chloride-Potassium (ACK) Lysing Buffer is used to lyse red blood cells in preparations containing white blood cells Examples include bone marrow buffy coats whole blood treated with EDTA All TheraPEAK Products are produced according to applicable GMP standards and follow the USP/EP guidance for cell and gene therapy raw materials It is the end user s responsibility to ensure full compliance with local regulations in terms of safety assessments and effective removal prior to patient exposure TheraPEAK Media Products are produced according to applicable GMP raw material standards and are intended to support GMP manufacturing TheraPEAK Media Products are produced at FDA registered manufacturing sites with an ISO 13485 certified quality management system