Pharmaceutical quality and plasma safety
Biotest combines compendial product quality, GMP manufacturing, controlled plasma sourcing and pathogen-safety measures with comprehensive qualification information.
Compendial and manufacturing framework
European Pharmacopoeia
Biotest HSA is manufactured in compliance with requirements for Human Albumin Solution, Ph. Eur. monograph 0255.
USP Information
Product information addresses USP-NF <1043> on ancillary materials and relevant USP requirements for human albumin.
GMP manufacturing
Biotest Human Serum Albumin is manufactured in Dreieich, Germany, according to GMP requirements and supplied under GDP.
Controls from plasma selection to final pasteurization
Safety is supported by qualified plasma sourcing, donor and plasma testing, cold ethanol fractionation and final pasteurization.
1. Qualified plasma sources
Licensed blood banks and plasmapheresis centres.
2. Testing and traceability
Donor qualification, viral marker testing, inventory hold and lookback procedures.
3. Fractionation
Cold ethanol fractionation contributes to virus and prion removal.
4. Pasteurization
Final heat treatment provides an additional virus-inactivation step.
Additional plasma-quality standards
IQPP Certification
International Quality Plasma Program covering donor management, donor health and centre-management standards.
QSEAL Certification
Quality Standards of Excellence, Assurance and Leadership covering plasma collection, processing and testing standards.
PPTA Membership
Plasma Protein Therapeutics Association membership supporting ethics, quality and safety standards, including IQPP and QSEAL, for plasma collection and manufacturing.
