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Updated: Apr 15, 2026

Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids
Published on: September 25, 2016
Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing
Abstract:
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.
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