Modern pharmaceutical manufacturing is, at heart, a discipline of predictability.
Small molecule and traditional biologics processes are anchored in chemically defined raw materials, tightly specified in-process controls and validated batches that behave — within known tolerances — the same way today as they did last quarter.
That worldview is codified in the regulations that most manufacturing chemists know intimately.
In the United States, 21 CFR Parts 210 and 211 define current good manufacturing practice for drugs; 21 CFR Part 610 sets biologics-specific standards for safety, purity, potency and lot release.1,2
In Europe, EudraLex Volume 4, the revised Annex 1 and the ICH Q-series play equivalent roles.3,4 Different jurisdictions, common logic: control the input, control the process and the output will be safe, effective and reproducible.
That logic remains valid. It is also being quietly stretched.
The US FDA's Chemistry, Manufacturing and Controls Development and Readiness Pilot (CDRP), its PreCheck programme, the MHRA's proposed overhaul of gene therapy definitions and the EMA's evolving ATMP guidance all point in the same direction: regulators themselves accept that the classical GMP model, applied without modification, does not fit living therapeutics.5,6
The reason is not a failure of the framework. It is a change in the raw material. Robert Marriott, Executive Vice President and Chief Quality Officer at Vitalant (pictured), takes up the story.
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