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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

by Emma Howlett | Feb 21, 2022

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and drug products have achieved this in many cases, biologics are behind the global implementation of CM because of their more complex...
A risk-based blueprint for process control of continuous bioprocessing

A risk-based blueprint for process control of continuous bioprocessing

by Emma Howlett | Jan 26, 2021

Phase one: Generic risk assessment and establishing process control parameters This paper  A risk-based blueprint for process control of continuous bioprocessing: Phase1: Establish process control parameters, gives an overview of an accompanying risk assessment...

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