Module 9 2024

03/09/2024

Module 3 Differences Inherent in Well Characterised Biologics

• While Module 3 is defined in the same general way in the current ICH M4Q, EU NtA etc a Module 3 for a well characterised Biologic will be different to a Module 3 for a Small Molecule product or a Module 3 for an Advanced Therapy Medicinal Product (ATMP) • Typically Biologic focus is much more on 3.2.S (vs 3.2.P. for most Small Molecules) as that is where the complexity primarily is • ATMP products are also quite different and guidance is continuing to evolve around these but as more such products get approved the agency expectations are becoming clearer. • Historically many ATMP products were out of scope of guidance but that is changing. • Often reflected in separate guidances (e.g. ICH, EU IMPD guidances etc)

The Organisation for Professionals in Regulatory Affairs

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Module 3 Differences Inherent in Biologics (cont.)

• These differences for Biologics stem from inherent and reasonable concerns around:

• Process variability – what is the potential impact of a small variable?

• Biological Assays – you cannot feasibly fully characterise most biologic products using current analytical methodology (what could this potentially hide?)

• Biological contaminants – TSE, viruses etc

• Biological target – how far can in silico or nonclinical models simulate human biology?

The Organisation for Professionals in Regulatory Affairs

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