In-vivo and in-vitro potency bioassays

Bioassay GmbH laboratories specialize in biopharma potency assays performed in-vivo and in-vitro.

Bioassay’s established in-vivo and in-vitro potency models can accurately assess quality control of active pharmaceutical ingredients and drugs. It also possesses extensive experience in developing and validating new assays under ICH-Guidelines, as well as optimizing existing assay formats for transfer into specific applications.

Bioassay GmbH has established a series of cGMP potency assays for antibodies, hormones, growth factors and Cytokines.

In-vitro potency bioassays

Bioassay’s analytical teams use in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m2 laboratories at Heidelberg Technology Park to 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.

Bioassay’s In-vitro potency assay portfolio covers antibodies, hormones and growth factors.

Bioassay similarly offers potency assays to reflecting the diverse mechanisms of antibodies, notably trastuzumab, adalimumab, infliximab, and etanercept.

Bioassay in-vitro potency assays provide a range of ADCC and CDC testing solutions, as well as FACS-based binding assays.

In-vivo potency bioassays

The Erythropoietin potency assay determines biological activity of erythropoietin by quantitative reticulocyte counts in flow cytometry (FACS), using GMP-certified execution of a validated method according to European Pharmacopoeia monograph no. 1316. Daily routines and analysis of more than 500 test samples per year assure high quality data. Bioassay extensive experience in research on erythropoietin analogues includes participation in international round-robin testing and contribution to Pharmeuropa publications.

Bioassay can also predict the potency of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH) and Human Chorionic Gonadotropin (HCG).

Compliance and transparency

Bioassay conducts and documents all biopharma potency assays in conformity with 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.