Module 9 2024

03/09/2024

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

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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 …

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