Bioassay method development and validation

products-servicesBioassay GmbH
March 19th 2020

The Heidelberg-based independent contract analytics laboratory Bioassay GmbH specializes in the development, validation and routine performance of bioanalytical assays (bioassays) in the areas of pharmacology and toxicology.

As the pharma and biotech industries increasingly turn to biologics for innovative therapeutic solutions, Bioassay GmbH has seen rising demand for its potency, efficacy and safety bioassays for method development and validation of new drug products. This is particularly so with large molecule therapeutics that demand well-controlled validated bioassay methods including analytical method validation protocols, cell cultures, sound design of experiment (DoE) strategies and minimal assay variability.

Bioanalytical assay method development is a critical necessity in biologic development and manufacturing. However bioanalytical validation is time and labor intensive while potential for higher variability than that found with analytical methods may lead to extended timelines to gather the data needed to support the full validation required for release through to stability testing.

Successful bioassay method development & validation

There are a number of essential steps and decision points to successful completing bioassays that can be fully validated. These include:

Essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics.

  • Preliminary planning, specifying timelines and decision points
  • Defining analytical method validation protocol (s) that apply
  • Designing methods with validation in mind, using design of experiments (DOE) and statistical analysis
  • Adopting a data-driven methodology with data capture and analysis during validation
  • Compliant handling of critical materials and cell line creating, characterization and handling
  • Rigorous process monitoring
  • Assessing readiness for validation with high quality control and documentation

Bioassay’s deep experience in bioanalytical assays provides a wider range of insights and tools, increasing success rate when developing and validating bioassays. This increased awareness of issues that can arise in biologics produces superior method development and validation strategies.

Each bioassay process involves review of relevant regulatory guidelines, selection of appropriate assay formats and platforms, use of standardized and pre-validated cell culture procedures and DOE design of assay.

Statistical resources need to be harnessed to the study and mechanisms mobilized to optimize assays during development, including managing assay variability, checking against validation requirements and working to re-defined methods, validation protocols, and SOPs.

ICH method validation

Bioassay GmbH specializes in the development, validation and routine performance of bioanalytical assays (‘bioassays’) in the areas of Pharmacology and Toxicology and is particularly expert in carrying out potency assays under GMP/GLP for biopharmaceuticals, including therapeutic antibodies, hormones and cytokines.

Bioassay offers a range of services based on in-vivo and in-vitro systems including potency assays (GMP) and toxicity Studies (GLP) and has developed a range of proprietary customized, product specific, assays in accordance with US Food & Drug Administration (FDA) standards and guidelines issued by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The Bioassay bioanalytical services portfolio focuses on three key areas:

  • Biopharma Potency: Bioassay GmbH executes and assesses potency assays for quality control of active pharmaceutical ingredients and drugs, developing and validating new assays under ICH-Guidelines, as well as optimizing existing assay formats for transfer into specific applications. These include pre-established cGMP potency assays for antibodies, Rituximab, Trastuzumab, Adalimumab and Infliximab.
  • Biopharma Efficacy: Established efficacy models to address the demand for characterization of new drugs, especially in biopharmaceutical fields like monoclonal antibodies, hormones and cytokines. Bioassay also has extended experience in characterizing biosimilars and modified biologics, such as pegylated products, and provides specialized models for characterizing nephrology and diabetes drug candidates. Cell-based Analysis services include FACS binding assays, specific cell line development and neutralizing antibodies assays, as well as a portfolio of pharmacokinetic and disease models that include metabolic studies and specific nephrology and diabetic models.
  • Biopharma Safety: A panel of assays for assessment of complex biotherapeutics ranging from monoclonal antibodies to recombinant proteins to characterize their interaction with different molecules in the human body to filter out possibilities of unwanted effects that might prejudice safety profile or compromise therapeutic efficacy. These safety panels cover antibody-dependent cellular cytotoxicity (ADCC), neutralizing antibodies, Multi-Cytokine Analysis, Immunotoxicology (ITOX3), skin sensitization (LLNA, Keratinosense, h-Clat & U-Sense) and toxicokinetics.


Independent Contract Laboratory specializing in the development, validation and routine performance of bioanalytical assays in the Life Science area