Module 9 2024

03/09/2024

A biological substance is a substance that is produced by or extracted from a biological source

Under cGMP conditions manufacture a Master Cell Bank (MCB) ~300 vials

Under cGMP conditions manufacture a Working Cell bank (WCB) ~300 vials

The Organisation for Professionals in Regulatory Affairs

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A biological substance is a substance that is produced by or extracted from a biological source

Key learnings

• The cell bank is our starting material for a biological such as a monoclonal antibody • It is manufactured in preparation for preclinical TOX material and must last the entire life cycle of the product. (~12 years of development, 20 years of commercial production or more!) • The cells in the bank are clonal, as our gene integrates into the genome of the cell and minor differences in cell can impact on product quality.

• Reading ICH Q5D and ICH Q5A

The Organisation for Professionals in Regulatory Affairs

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