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EU Pharmacopoeia Adopts ‘Groundbreaking’ Cell Therapy Chapter, Seeks Feedback On Alternative Microbiological Tests

 
• By Neena Brizmohun

A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.

Scientist, woman and writing notes for research, test and chemical analysis for health innovation in lab on microscope
The European Pharmacopoeia is compendium of texts on the tests to be carried out on medicines (Shutterstock)
Key Takeaways
  • A new chapter on cell-based preparations for human use will be published in issue 12.2 of the European Pharmacopoeia in October and enter into force on 1 April 2026.
  • The pharmacopoeia is also seeking feedback on significant revisions to its general chapter on alternative methods for the control of microbiological quality.
  • The revisions aim to accelerate the implementation of alternative rapid microbiological methods, which are especially beneficial for short shelf-life products, and they are out for public consultation until the end of June.

The European Pharmacopoeia (Ph. Eur) will soon include what is said to be a groundbreaking chapter on cell-based preparations for use by developers of advanced therapies. In addition, feedback is...

The new chapter on cell-based preparations for human use (5.32) will provide a comprehensive framework for the production and quality control of cell-based preparations, while offering the flexibility required to...

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