Advancing a drug candidate from the discovery stage to clinical phases requires a well-defined process research and development plan to identify and troubleshoot poor performing steps, redesigning new routes, and replacing them with less expensive well-performing processes. This would reduce the operational costs, shortening the production time, and bring the drug products to market faster.
With over 35 years combined experience in pharmaceutical research and development, CalChem’s management and staff are available to enhance your multi-step discovery projects and prepare them for a successful transfer to advanced clinical phases.(process research)

After all, development studies are complete and a robust process is identified, demonstration batches of key intermediates or APIs will be performed as a Proof-of-Concept for the selected processes.  At the conclusion of the process R&D, a technology transfer report capturing detailed synthetic efforts and analytical data, including In Process Control (IPC) results, will be prepared and submitted to clients.  The Technology Transfer Reports prepared by CalChem will be essential packages for successful transfer of drug candidates from discovery to clinical, with no or minimal need for further process development in manufacturing sites.

EXAMPLES OF TYPICAL DEVELOPMENT STUDIES DURING THE PROCESS R&D:

Evaluate synthetic routes to identify problematic steps of the synthesis or sequences that are not compatible with large scale production

Design new synthetic routes to optimize or eliminate troublesome steps

Perform laboratory experiments to assess the newly designed routes

Fully optimize the reaction conditions to develop a robust process, maximize throughput, and reduce production cost using classical methods or statistical design of experiments (DOE)

Evaluate the type of solvents and reagents used in the process and replace Class I and II solvents with Class III solvents, wherever applicable, to comply with ICH guidelines

Optimize the purification conditions to minimize chromatographic purifications and replace them with reproducible crystallization methods

Develop reliable analytical methods for In-Process Control (IPC) of intermediates and APIs

Perform demonstration batches as Proof-of-Concept (POC) for the newly developed processes

Prepare a Technology Transfer Report summarizing all developmental studies and analytical data for submission to manufacturing sites

Identify Critical Process Parameters (CPP) for specific projects that are in advanced clinical phases (normally phase II) to support clients’ cGMP programs

As part of these services, CalChem also offers rapid optimization of existing clients’ procedures, which were typically performed on milligram to gram scale, to make them amenable for large scale synthesis.  If your discovery program needs rapid scale-up of an existing medicinal chemistry synthesis to multi-gram or kilogram quantity, our expert team of chemists can rapidly and reliably perform it to your specific need.