CRED Getting the CMC Dossier Right 2024

28/08/2024

Drug Substance Development: Some of the Challenges

Strategic considerations

Technical considerations

• Supply clinical API and phase appropriate data package whilst planning for registration

• Impurities (process related, mutagenic, nitrosamines, elemental, solvents)

• Clinical and DP development API needs can be high

Form control

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DS properties to suit DP QTTP

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• Long complex supply chain and tight timelines

Stability

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• When to invest in registration related activities and when to change process

Cost of goods

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• Manufacturing flexibility and efficiency

Regulatory expectations

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Green chemistry

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Global regulatory divergence

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The Organisation for Professionals in Regulatory Affairs

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Development Team Members

Project Management

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Quality

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Analytical

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Commercial

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Drug product

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Patents / Legal

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Chemistry

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Clinical Supplies

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Drug safety

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Clinical Operations / Manufacturing (Internal and Outsourcing) Commercial Operations / Manufacturing (Internal and Outsourcing)

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Clinical

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Regulatory

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The Organisation for Professionals in Regulatory Affairs

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