process validation - Bioprocess Development Forum

Articles Downstream Upstream

January 30, 2020

Mapping a Route for Cell and Gene Therapy Process Development

The regenerative medicine field is still quite young, and companies developing commercial processes...

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Articles Downstream

April 11, 2019

New HiScale™ 10/40 for Scale-Down Studies

Cytiva is pleased to announced the new HiScale™ 10/40. HiScale 10/40 column is especially suitable...

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Articles BioPharma Regulatory

April 12, 2018

Understanding Validation and Technical Transfer, Part I

Many new biological entities use unique processing flows and steps that can require non-traditional...

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Articles

March 15, 2014

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances...

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