GMP Flow Cytometry: Applications, Considerations and Challenges

This webcast features: Jamie Hall, Project Manager, Center of Excellence for Biopharmaceuticals, Intertek Pharmaceutical Services

Flow cytometry is a powerful technique which can be applied to all stages of the drug development pipeline including discovery, clinical development, CMC, regulatory submission and in support of production. It allows the analysis of complex mixtures of particles, from polystyrene beads to cells. Utilizing a broad spectrum of fluorescent detectors, assays can be set up to assess multiple parameters at once and ascertain otherwise hidden detail. One of the key strengths of flow cytometry is its flexibility and broad application range including immunophenotyping, cell line identification and cell-based potency assays.

In a regulatory environment this flexibility can present challenges. Day to day instrument variation and the potential for subjective interpretation of data can have huge implications. For this reason, the selection of instrumentation and implementation of quality systems is crucial when working in a regulatory environment.

In this Ask the Expert webinar, Intertek’s flow cytometry expert and regulatory project manager, Jamie Hall, describes key applications, considerations for implementing methods in a GMP environment and typical challenges which must be overcome.

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