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
9
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
10
5
Made with FlippingBook Online newsletter creator