Regulatory and Monetary Drivers for Real-Time Analytics

By Barry Rosenblatt, PhD

Volume 15, Issue 1 (Spring 2016)

Implementation of ā€œreal-timeā€ analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development processā€¦

Citation: Rosenblatt B. Regulatory and monetary drivers for real-time analytics. BioProcess J, 2016; 15(1): 5ā€“9.Ā https://dx.doi.org/10.12665/J151.Rosenblatt

Posted online April 7, 2016

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Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

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