Newsletter | July 22, 2025
FEATURED EDITORIAL
Essential Steps For A Successful Analytical Tech Transfer
By Rishi Ramesh Kothari, gene therapy CMC expert
Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.
What Did ICH Q14 Miss On Analytical Method Validation?
By Joachim Ermer, Ph.D., GMP Compliance Adviser
Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.
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