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Design, Development and Validation of Cell-based Bioassays

In-House Training

TRAINING OVERVIEW

For the release of biotechnological products, potency is a mandatory critical quality attribute that manufacturers must evaluate to ensure it conforms to specifications for releasing drug substance and drug product batches. Cell-based bioassays are commonly used to determine potency. While binding assays, including non-cell-based assays, can be considered during early clinical development, regulatory bodies expect that cell-based bioassays reflecting the mechanism of action of the biotherapeutic be developed and implemented during late clinical development. These assays should then be appropriately validated before performing the process performance qualification. This Master Class addresses common bioassay formats, as well as the development and validation of bioassays.

  • Use the proper terminology of bioassays and their validation

  • Know the major sources of information

  • Understand biological activity vs potency and purpose of bioassays

  • Understand parameters that could affect the outcome of bioassays

  • Implement appropriate approaches for cell line development, cell bank establishment and testing

  • Know-how to design bioassays, including: fitness for use, concept of relative potency, assay optimization, determination of standard curves, and statistical considerations

  • Master the validation of bioassays in accordance with pre-defined acceptance criteria

  • Check for robustness of bioassays

  • Provide examples of bioassay formats and case studies

  • Bioassay development scientists

  • Bioassay validation personnel

  • Stability scientists

  • QA/QC personnel

  • Regulatory CMC

  • CMC project managers

AGENDA

  • Bioassays and validation terminology

  • Regulatory guidelines and bibliography

  • What bioassays are and their purpose

  • Common bioassay formats and regulatory expectations for reflecting the mechanism of action of a biotherapeutic

  • Cell line development, cell bank establishment and testing

  • Design and development of bioassays, including assay parameters

  • Bioassay validation

  • Satistical considerations

  • Suitability testing

  • Analysis of bioassays

  • cases studies, including the replacement of in vivo assays with cell-based in vitro bioassays

  • Questions and answers

Interested in this course?

Please contact us at mylene.talabardon@biotechnologyconsultant.com