Bioassay bioanalytical method development and validation for GxP compliance

Bioassay GmbH specialize in bioanalytical method development and validation focusing on pharmaceutical potency, efficacy, and safety assays. Bioassay conducts and documents all biopharma assays in conformity with GLP & GMP standards, in conformity with FDA, EMA, ICH and other regulatory agencies guidelines, which form the basis for its quality and reliability. This compliance guarantees acceptability of data generated for product licensing.

Bioassay’s analytical teams use in-vivo and in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m² analytical and assay laboratories at Heidelberg Technology Park to conduct established cGMP and cGLP assays.  The Bioassay portfolio covers a very wide range of testing solutions for drug products and biologics, including proteins, monoclonal antibodies, hormones and cytokines, vaccines, and gene therapies.

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

GxP analysis and validation

Bioassay capabilities include proprietary method development, regulatory compliant analytical and assay validation, method transfer, high throughput sample analysis and pharmacokinetic and toxicokinetic assays, combined with automated data capture and reporting systems.

Recognizing the crucial role of bioanalytics in GxP compliant drug development, Bioassay seeks to deliver consistently accurate and reliable data that comply with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines. The data must be sufficiently robust to withstand rigorous scientific and regulatory review as the pathway to successful discovery, preclinical and clinical programs.

Bioanalytical testing and validation services cover large and small molecules and include support for GxP method development such as ensuring assays comply with ICH and FDA guidelines for method validation,  as well as ICH analytical method validation protocols.

These services also cover pharmacokinetic (PK) analysis, bioavailability and bioequivalence studies, lead optimization studies for drug efficacy, and dose formulation analysis based on potency and can be used to support all phases of drug development.

Method Development

Bioassay’s method development expertise covers potency assays for a variety of for drug products and biologics, including proteins, monoclonal antibodies, vaccines, and gene therapies. The team will work with their biopharma customers to select the most appropriate assay format and design a robust and sensitive method before method transfer or moving to routine testing.

The Bioassay assay laboratory teams follow GMP guidelines, FDA bioanalytical method validation and EMA bioanalytical method validation guidelines to validate potency assays, including establishing accuracy, precision, linearity, and specificity. The method validation process is designed to ensure that the assay is reliable and reproducible, providing confidence in the potency results.

Resources

Click on Bioassay Service Overview for further information.