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The Chemical Development & Medicinal Chemistry Interface
Even during pre-clinical stages our clients need to think ahead to Chemical Development: to ensure pre-clinical supply, speed up & reduce costs of clinical supply.
Charnwood Molecular’s PR&D team has over 100 years of combined large pharma experience. It provides excellence in pre-clinical Process Chemistry R&D and enables a smoother transition between Medicinal Chemistry and Chemical Development for our clients through the provision of focused early Development support programs which deliver:-
• Pre-clinical non-GMP supply (up to 0.5kg)
• Process Chemistry R&D to access efﬁcient chemistry (High yields, robust, fast throughput)
• Enhancement of Out-licensing offering (including methods & samples)
• Increased value, de-risked project, API supply ensured
• Excellent Technology Transfer to cGMP Scale-up
As most development activities are dependent on an adequate supply of API, it is important to keep the Chemical Development activities a phase ahead of the requirements of other departments. Although initial quantities of the API provide the fuel for the Development engine, ultimately, it is the quality of the manufacturing process that will be the most valuable output from the PR&D effort. Chemistry problems are solved more efﬁciently and economically in the laboratory rather than on plant, where costs increase 15-fold.
Effective PR&D saves time and costs in New Product Development. Inefﬁcient chemistry can cost a project up to 18 months in time, negatively impacting New Product Value (NPV) by up to 30%.
The 20-50kg campaign is often the real rate-limiting delivery stage, with a major impact on NPV. This needs to be considered early and Charnwood Molecular’s PR&D group can help you do this.
More information on our Chemical Development expertise can be found here: