Module 9 2021

19/03/2021

Example Approach to Identify Material Attributes and Process Parameters

Intermediate CQAs Duration of Cell Culture

Process Variables Population Doublings

Product CQA % Glycosylation

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Methods are a Vital Part of the Process

• The ability to compare biological materials is solely dependent on the tests used:  No single analytical method is able to compare every aspect of protein structure or function.  The advantages and disadvantages of any given method depends on the protein property being characterized.  Sensitive and suitable methods are required to meaningfully detect change  Orthogonal methods are encouraged

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