Process Optimization in Drug Development

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Patent Preparation Expert Witness

New Product Acquisition Drug Delivery Systems

Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

After the formulation is decided and the basic processing determined, it is necessary to optimize each unit process to ensure a robust formulation. Generally, as the project progresses and the clinical studies expand, the process is scaled up, eventually approaching a scale that is close to commercial scale. Scale-up is not necessarily straightforward. The dynamics of granulation and mixing, for example, are such that it can be difficult to predict what will happen on scale up. Nevertheless, with experience success can be achieved.

FinnBrit Consulting has experience in process optimization and can advise clients accordingly.

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