Module 9 2021

Consequences of advances in technology

New hazards become apparent

• Contaminants in starting materials – With biological/pathogenic activities - viruses – New agents – TSE

• Very difficult to test at low levels due to insensitivity of bioassays – Endogenous viruses – Adventitious agents

• Raw material control becomes critical – Provenance, traceability (geographical origin) – Testing, validation

The Organisation for Professionals in Regulatory Affairs

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Consequences of advances in technology

• Need to demonstrate process capability – Inactivation/removal of viruses – Beyond the likelihood of reaching the patient

• Effects of process inconsistency – Changes in product attributes • Post-translation changes • Impact on potency → efficacy

• Consequences for safety → immunogenicity • Product = process …

The Organisation for Professionals in Regulatory Affairs

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