Drug Substance Development Options for Effective API Commercialization

The need for contract API/drug substance manufacturing in the pharmaceutical and biotechnology industries continues expanding. The requirements for complex chemicals to facilitate new innovations in drug development- combined with advances in technology and ever-changing regulatory requirements- pose challenges for all drug development firms. The determination of whether an API synthesis route is scalable and suitable for commercial production is also critical for successful drug development. Richman Chemical Inc. (RCI) is a reliable partner through this step as well as the full gamut of drug substance R&D, pre-clinical evaluations, and clinical phase studies.

RCI’s ability to manage crucial stages of synthetic-focused drug development process makes us an ideal partner for API/drug substance manufacturing.  When start-up firms prepare to enter pre-clinical/early stage clinical studies, they require smaller amounts of material. Assuming data from early phase work demonstrate promise, they then confront the daunting task of transferring the process to another supplier capable of capable of supplying quantities for late phase/commercial stages.  RCI can effectively handle the entire program workflow from R&D through commercial manufacture.

Further, RCI excels at tailoring its program phase offerings for each client.  This includes offering Full Time Equivalent (FTE) options (early development through pre-clinical), Fixed Bid proposals, or a combination of each.  The needs of each drug development client differ considerably-  RCI understands this and offers innovative solutions.

Overall, RCI’s emphasis on domestic manufacturing and a practical, stage-wise approach to drug substance commercialization makes it an excellent choice as a CDMO partner.  From early stage R&D through to commercial production, RCI’s suite of services is complete!