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 selection

Virus inactivation/removal within the manufacturing process

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.