Safety and quality aspects
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Along with our internal controls, our standards ensure consistent high quality and safety in the production of Biotest Human Serum Albumin.
The safety of Biotest Human Serum Albumin with respect to pathogenic viruses and prions is based on careful selection and testing of the raw materials for manufacturing, and on proven effective virus and prion inactivation/removal steps during the manufacturing process.
All raw materials used are pharmaceutical grade ingredients. None of the starting materials used in the manufacturing process of Biotest
Human Serum Albumin are affected by the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy via Medicinal Products” and its updates published by the European Commission, as referred to in the Annex to Commission Directive 2003/63/EC amending Directive 2001/83/EC concerning TSE.
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.
Virus inactivation/removal within the manufacturing process
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.
International Quality Plasma Program (IQPP) and Quality Standards of Excellence, Assurance and Leadership (QSEAL) were developed by the Plasma Protein Therapeutics Association (PPTA). IQPP provides independent, third-party evaluation and certification that manufacturers use the highest quality source materials. The QSEAL Program is an independent certification of adherence by fractionators to the voluntary standards concerning the quality and safety of incoming plasma used for manufacturing plasma protein therapies.