By Takehiro Okumura and Zeb Khan, Takeda Pharmaceuticals

Published in: Cell & Gene

Published on: April 5, 2024

Regulatory agencies allow for manufacturing materials such as genome editing materials, the generation of iPS cells, and the subsequent selection process under principles of GMP or GMP-like operation instead of full GMP compliance. This article explains how to implement GMP principles in non-GMP settings, also known as GMP-like, and the quality oversight required for implementation.

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