FTO Analysis in Biopharmaceutical Development Essential for Avoiding Patent Infringement During Stability Testing.

Generic drug manufacturers must conduct a thorough Freedom to Operate (FTO) analysis when developing biopharmaceuticals to avoid potential patent infringement risks and ensure regulatory approval. The analysis is especially crucial during stability testing, a key component of drug development. An FTO analysis, in this context, examines the intellectual property landscape surrounding the drug’s active pharmaceutical ingredient (API), formulation, and manufacturing process. The FTO analysis necessitates a detailed review of existing patents related to the API, formulation, and manufacturing process. Manufacturers also need to confirm their biopharmaceutical meets all relevant regulatory guidelines, specifically regarding stability testing, labeling, and packaging. Formulating and validating stability testing protocols is vital for meeting regulatory demands and assuring the drug’s long-term stability. A validated manufacturing process ensures consistency, reliability, and non-infringement of existing patents.

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Source: https://www.drugpatentwatch.com/blog/conducting-a-biopharmaceutical-freedom-to-operate-fto-analysis-key-considerations-for-generic-drug-stability-testing/ Mon, 31 Mar 2025 08:14:40 +0000

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Author

Mark Chiang