Module 9 2024

03/09/2024

Process Automation and Scale-Out

Open and close handling

● Process closeness definition ● Aseptic processes and sterile products Manufacturing environment ● Fully closed system: call for rendering clean rooms obsolete? ● Equivalent to GMP manufacturing ● Decentralized production Risk of microbial contamination

Faster scale out to meet increase demand, supply chain and provide more cost-effective products Process Automation ● Provide more control reducing in-process variation ● Reduce the cost Devices for Process Automation: Modular systems and all-in-one systems ● CliniMACS Prodigy (Miltenyi): approved by EMA for commercial manufacturing ● Cocoon (Lonza) ● Quantum (Terumo)

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Comparability

Source of changes ● New (improved) reagent grade / New suppliers for biological derived reagents ● Process scale up / transfer to new facility ● Improved genetic design Scope of comparability ● Demonstrate consistency of pre and post-change material ● Demonstrate the does not adverse affect quality, safety and efficacy Similar approach as for biosimilars ● ICH Q5E: Comparability of biotechnological/biological

● ICH Q8: Pharmaceutical development ● ICH Q9: Quality risk management ● ICH Q10 Pharmaceutical quality system

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