Module 9 2024

03/09/2024

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

Insert vector into host cells (transfection)

Chinese hamster ovary cells (CHO)

Plasmid

Apply selection pressure

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

Apply selection pressure

Evidence of clonality required by regulatory authorities

‘for recombinant products, the cell substrate is the transfected cell containing the desired sequences, which has been cloned from a single cell progenitor) (Q5A)

Methods include - Limited dilution (two rounds)

Cloning

The Organisation for Professionals in Regulatory Affairs

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