platform manufacturing
- Guideline or reference source
- ICHQ11 Development and manufacture of drug substances
- Definition
- The approach of developing a production strategy for a new drug starting from manufacturing processes similar to those used by the same applicant to manufacture other drugs of the same type (e.g., as in the production of monoclonal antibodies using predefined host cell, cell culture, and purification processes, for which there already exists considerable experience).
- Related Term
- manufacturing
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