TORONTO, March 28, 2018 (Newswire.com) - Potency of biotherapeutics, often determined by cell-based assays, is one of the most important critical quality attributes. Potency must be monitored throughout the entire drug development cycle as it measures drug activity and provides a direct link to clinical efficacy. An ideal potency assay should represent a drug’s mechanism of action (MOA), as well as be specific and sensitive enough to detect changes and degradations of the product. Cell-based potency assays are intrinsically complex and may present challenges during development, validation, transfer and implementation.
This presentation will highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP <1032> and <1033>) and are suitable for CGMP stability testing. In addition, a phase appropriate potency method development and qualification/validation strategy will be discussed. Practices in support of successful cell-based assay transfer and long-term maintenance of the assay in the QC laboratory will be presented.
The discussion including a Q&A session with the audience will benefit biopharmaceutical/biotechnology industry professionals involved in quality assurance/quality control and regulatory affairs for biologics, as well as validation specialists and outsourcing professionals.
Key topics include:
- Challenges in establishing a robust cell-based potency assay
- Routine assay performance monitoring
- Analyst training and qualification requirements
- Analytical working cell bank generation and characterization
- Cell maintenance and growth tracking
- Bridging studies for critical reagents
On Tuesday, April 17, 2018, at 2 p.m. EDT, join experts from Nitto Avecia Pharma Services, Aryo Nikopour, senior vice president of scientific and technical services, and Ming Li, principal scientist/team lead for Biopharmaceutical Development, for an informative session.
For more information about this complimentary event, visit Cell-Based Assays in a CGMP Environment: Approaches for Clinical and Commercial Stability Studies.
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