Critical steps when validating an assay or analytical method for cell and gene therapy products

Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.


When developing a process workflow for your clinical or commercial product, there are several variables that must be considered. Many early‑stage gene therapy companies use techniques common in academic labs such as adherent cultures, which use foetal bovine serum (FBS), freeze-thaw lysis and ultracentrifugation. We call this the starting point, or “as-is” process.

The aim when developing a process is to improve manufacturing scale, robustness and cost, while achieving the necessary levels of quality and safety that are vital for therapeutic products.

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