Module 9 2021

19/03/2021

Biotech Products are Larger and More Complicated than Chemical Drugs and have Fragile 3-D Structures

Chemicals

Biotechnology

Aspirin: molecular weight 180 Da

Monoclonal Antibody: Molecular Weight 150,000 Da Chiu M.L Antibody Structure and Function: The Basis for Engineering Therapeutics. 2019. Antibodies 8(4), 55

The Organisation for Professionals in Regulatory Affairs

5

Heterogeneous Population

ICH Q6B - The manufacturer should define the pattern of heterogeneity of the desired product and demonstrate consistency with that of the lots used in preclinical and clinical studies.

The Organisation for Professionals in Regulatory Affairs

6

3