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Based on the APIs and intermediates we developed and developing, the management team and staff at Evershine have extensive experience in pharmaceutical scale-up research and development that spans many decades of practical, hands on expertise.
Clients seeking to improve troublesome steps in a process, reduce the cost of goods by removing expensive or poorly performing steps, or re-design an entire route for one of their potential products or key intermediates, will find value added input at the chemistry level.
Our research team works closely with the analytical team to integrate the chemistry and analytical controls into the process at an early stage of the development cycle. The research is at last documented into a development report that outlines the chemistry and synthetic approaches that were tried as part of the synthetic development effort. This report also includes a detailed experimental with supporting analytical data for the successful chemistry that results from our effort which is much more detailed than any journal publication. The process we develop provides the foundation of the ultimate manufacturing process, and should not need any changes (at a later date), to the synthetic strategy or bond forming steps used to prepare the API. Shown below is a listing of the typical services that we offer as part of the scale-up process research effort:
- Evaluate the existing synthesis and identify steps, or sequences in the route that may pose a problem for large scale synthesis
- Propose alternatives to any problematic steps or sequences and then implement these alternatives bases upon laboratory experimentation using Ph.D. level chemists with process research expertise
- Ensure the synthesis is suitable for the immediate needs of the project, which maybe for only a few kilograms of API
- Ensure the synthesis is suitable for long term, large scale manufacturing
- Optimize reagent charges, operating temperatures, concentrations, work-up conditions and volumes, and solvent use in general
- Identify which steps can be combined to result in a “through process” and implement the through process
- Optimize purification schemes by identifying key crystalline intermediates and remove chromatographies from the synthesis
- Optimize recrystallization parameters to ensure consistently high purity with similar impurity profiles from batch to batch, with low mother liquor losses
- Institute appropriate analytical controls for in-process assays, end of reaction specifications, and acceptable intermediate or API purity
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