Plasma is only obtained from blood banks and plasmapheresis centers that hold a valid manufacturing license and thus are authorized by the relevant national competent authority. The collection of blood and plasma is carried out according to the CHMP “Guideline on plasma derived medicinal products” (European Medicines Agency, EMA/CHMP/BWP/706271/2010), Annex 14 of the European Union (EU) Guide to GMP on “Manufacture of products derived from human blood or plasma”, and complies with the European Pharmacopoeia monograph “Human Plasma for Fractionation” (Ph. Eur., current edition, No. 0853). All plasma suppliers must be approved by the EMA in accordance with the ”Guideline on the scientific data requirements for a Plasma Master File (PMF)”(CHMP/BWP/3794/03). The Plasma Master File is updated annually.
Furthermore, Biotest adheres to the comprehensive standards defined by the international quality programs QSEAL and IQPP of the Plasma Protein Therapeutics Association (PPTA) comprising donor qualification, viral marker alert limits, inventory hold, extended NAT testing and lookback procedures.

Biotest Human Serum Albumin fulfills the requirements of both the German and European guidelines for a pharmaceutical product derived from human plasma and provides high safety margins with respect to infectious viruses and prions, the infectious agents of transmissible spongiform encephalopathies (TSE).

Effective virus inactivation and removal capacity is provided by cold ethanol fractionation steps and by final pasteurization of the albumin solution. Cold ethanol fractionation has also been demonstrated to ensure effective removal of prions, should they be present.
The proven clinical safety record of albumin purified from human plasma is that in more than 60 years of use, no albumin preparation produced in line with European regulatory guidelines has been reported to have transmitted infectious viruses, as also recognized by the EMA in CHMP / BWP / 360642 / 2010 Rev. 1. It is notable that this excellent record of safety was established when plasma screening techniques were far less powerful than today. Given today’s stringent plasma testing regimen, even higher margins of safety would apply.