Publications

The CMC chasm. Why most biotech IND submissions fail at chemistry, not biology.

Author: Andrew Jonathan Hillman (ORCID 0009-0001-5396-321X)
Published: , Zenodo. Also published in The Hillman Letter.
DOI: 10.5281/zenodo.23352278 (all versions); this version 10.5281/zenodo.23352279
License: CC BY 4.0

Abstract

Explains why the Chemistry, Manufacturing, and Controls section is a frequent cause of IND clinical holds. Describes what CMC covers under 21 CFR 312.23(a)(7) and how sponsors should build it as a program rather than paperwork.

This essay describes FDA regulatory process for educational purposes. It is not legal or regulatory advice.

Read the PDF on ZenodoPermanent DOI recordRead on The Hillman LetterOpenAlex record

Indexed in OpenAlex under author A5139488776.

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