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Cell- and Virus-Bank Characterization in Product Development: A Risk-Based, Phase-Appropriate Framework for Quality Control

By

Gwenaël Autret

1d agoen
science

Source

bioprocessintl.comCell- and Virus-Bank Characterization in Product Development: A Risk-Based, Phase-Appropriate Framework for Quality Controlbioprocessintl.com
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The breadth of cell substrates, raw-material inputs, and manufacturing platforms in clinical development is broader than what current guidances were designed to regulate. Thus, cell-bank characterization programs need to keep pace and increase in efficiency. The author proposes a structure for organizing the choices that development teams need to make.

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