Complete Biological Testing Package for Identity, Purity and Activity

Eurofins BioPharma Product Testing Munich offers tailored biological testing services such as testing for identity, purity and activity. Our service portfolio has been expanded with Protein Analytics which complements Bioassays / Potency Testing and Microbiological Testing. Comprehensive Release and Stability Testing Packages in compliance with regulatory requirements of the Good Manufacturing Practices (GMP) can be designed to support development and manufacturing of biopharmaceuticals.  

Protein Analytics

We support testing of all process-related impurities such as residual Protein A, DNA, and host cell proteins (HCP). In addition, for product related substances/impurities, i.e. post translational modifications, assays must be employed to ensure that any impurities present are below pre-determined acceptable levels. Here all techniques such as ELISA, MSD, chromatography and capillary electrophoresis have been established. Physical and chemical testing, i.e. pH, appearance, osmolality or particles complete the protein analytical testing package. Learn more

Bioassay and cGMP Potency Testing

In vivo and in vitro Bioassays are essential for testing biopharmaceutical bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets. They are performed to determine the biological activity or potency of the product, a critical quality attribute according to ICH Q6B. Eurofins BioPharma Product Testing Munich develops, transfers and validates tailor-made cell-based bioassays and binding assays utilizing state-of-the-art instruments such as SPR, MSD, FACS, and automation systems. Learn more

Microbiology

We offer microbiological testing such as endotoxin, sterility, bioburden for quality control of raw materials, bulk goods, end products and storage studies, as well as for validation of plants and production processes. In addition, numerous study designs are available for product development. Our experts are always up to date with current trends and regulatory issues due to their profound knowledge of current guidelines (IO, DIN, EN, Pharmacopoeia, AAMI, ANSI, ASTM etc.) and their regular participation in international working groups and congresses. Learn more

Please contact us to receive a quote or discuss your needs with our experts in Munich.