Download your free white paper: Regulatory considerations for analytical method development in gene therapy

Analytical methods are crucial for developing gene therapies, especially as the field of cell and gene therapy matures and therapies become more complex. Consequently, the need for highly accurate analytical methods has grown.

Thermo Fisher explore the key factors impacting analytical method development in gene therapy, plus learn:

  • The vital role of analytical methods in gene therapy development
  • The varying types of analytical assays on offer – from characterization, in-process and release assays
  • The importance of risk-based approaches and guidelines ICH Q14 and ICH Q2(R2)
  • How to minimize regulatory risks through early collaborative discussions with FDA
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