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W103b

Strategies for Setting Patient-centric Quality Standards

Date
May 13, 2020
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Thumbnail for CMC Strategy Forum Europe 2020
The purpose of the CMC Strategy Forum Europe 2020 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade…

The traditional method of creating specifications and control strategies based primarily on material, and thus its associated attributes, used in clinical studies can create limitations for the supply of medicinal products and hamper continuous improvement efforts. Other sources of data should be considered that allow for an increased understanding of what is relevant to the patient – the patient centric approach. This data can be product or class specific and come from prior knowledge, in vitro and in vivo studies, molecular modeling etc. This provides a more relevant and holistic data set on which to base the tests and limits that make up a patient centric control strategy

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Thumbnail for Applying Patient-centric Quality Standards Concepts to Biotechnology and Advanced Therapy Products
Applying Patient-centric Quality Standards Concepts to Biotechnology and Advanced Therapy Products
The current practice in establishing specifications as defined in ICH specification guidelines is essentially based solely on clinical experience…