2026_Contact_Envelope

Supporting Confident Manufacturing Changes: How Kerry (formerly c-LEcta) helps You Navigate FDAs New Regulatory Flexibility

Author /

In January 2026, the U.S. FDA publicly reinforced a flexible, risk-based approach to CMC requirements for cell and gene therapies. The agency emphasized that minor manufacturing changes can be supported by focused, science-driven comparability data rather than disproportionate revalidation efforts: See here!

This regulatory approach strongly aligns with  Kerry's (formerly c-LEcta) Change Guidance Documents, which help manufacturers manage raw and ancillary material changes in approved biopharmaceutical manufacturing processes.

Kerry provides customers with clear, regulatory-aligned support for an efficient and confident implementation of changes covering

  • Defined qualification elements

  • Structured Risk assessments

  • Targeted Comparability activities.

Together, FDA’s clarified flexibility and Kerry's practical change guidance underscore a shared principle: manufacturing change is a normal, expected part of a product’s lifecycle - and, with the right scientific framework and regulatory support, it can be executed efficiently, safely and without unnecessary delay.

Whether you are considerung the replacement of a trypsin-like enzyme or an endonuclease in your approved manufacturing process - Kerry's Change Guidance Documents help you navigate raw and ancillary material changes with confidence, using a regulatory aligned framework.