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GMP Flow Cytometry: Applications, Considerations and Challenges
Flow cytometry is a powerful technique which can be applied across the drug development pipeline including discovery, clinical development, CMC, regulatory submission and in support of production. 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 whitepaper, one of Intertek’s flow cytometry experts 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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