Module 9 2021

16/03/2021

Module 3 Differences Inherent in Biologics

• While Module 3 is defined in the same general way in ICH M4Q, EU NtA etc a Module 3 for a Biologic will be different to a Module 3 for a Small Molecule product

• Typically Biologic focus is much more on 3.2.S (vs 3.2.P. for most Small Molecules)

• Often reflected in separate guidances (e.g. EU IMPD guidance)

• ATMP products are also quite different and guidance is continuing to evolve around these but as more such products get approved the agency expectations will become clearer.

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 a biologic using current analytical methodology (what could this potentially hide?)

● Biological contaminants – TSE, viruses etc

● Biological target – how far can nonclinical models simulate human biology?

The Organisation for Professionals in Regulatory Affairs

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