BioPharma Potency Assays

BioPharma Potency is one of four key focus areas for Bioassay GmbH laboratories, along with BioPharma Efficacy, BioPharma Safety and Chemicals / Cosmetics Safety.

Bioassay’s analytical teams using in-vivo and in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m2 laboratories at Heidelberg Technology Park can execute and assess potency assays within quality control and development regimes for a wide range of active pharmaceutical ingredients (APIs) and drug products.

Further, Bioassay has extended experience in developing and validating new potency assays accordingly to ICH-Guidelines as well as in optimizing existing assay formats and transferring data into routine applications.

BioPharma Potency Portfolio

Bioassay has developed a series of established cGMP potency assays covering three different arenas:

Antibodies

• Rituximab
• Trastuzumab
• Adalimumab
• Infliximab
• Etanercept
• Antibody Dependent Cellular Cytotoxicity (ADCC)
• Complement Dependent Cytotoxicity (CDC)
• FACS-Based Binding Assays

Hormones

• Erythropoietin
• Follicle Stimulating Hormone (FSH)
• Luteinising Hormone (LH)
• Human Chorionic Gonadotropin (HCG)
• Parathyroid Hormone (PTH)

Growth Factors & Cytokines

• Filgrastim (G-CSF)
• Human Growth Hormone (hGH)
• Interleukins

Specialized potency assays

For further products or to meet specific customer requirements, Bioassay has a comprehensive library of existing specialized assay formats. Its analysts can also develop customized assays at short notice.

Biopharma potency assays combine standardized processes with flexible organization, adapting constantly to changing needs. Project managers are assigned to each customer at both operative and administrative levels, to accompany the client through all stages of their projects.

This combined approach enables Bioassay to extend the scope of its assay services.

Compliance and transparency

Bioassay conducts and documents all biopharma potency assays in conformity with GLP & GMP standards, which form the basis for its quality and reliability standards. This compliance guarantees acceptability of data generated for product acceptance and licensing.

Bioassay quality standards are inspected by leading regulatory authorities and in customer audits. These serve to encourage continuous improvement and reinforce transparency.

All customer-specific data and processes are handled and stored with utmost discretion and confidentiality.

Resources

Click on BioPharma Potency Assays for more information.
Click on Bioassay to contact the company directly.