Novel Chemical Excipient
A medical device company had an urgent need for a critical Excipient for their new product in advanced clinical trials. The Excipient was a novel organic chemical compound that when combined with the medical device provided the desired properties. The MD company, however, had a BIG problem: they manufactured medical devices but had no expertise in the organic chemical synthesis experience!
Soon after contacting Richman Chemical, the MD company’s fears were alleviated. We were able to evaluate some rudimentary technology for custom synthesis of the molecule provided by the company, and then take it from there. We collectively optimized the chemical synthesis process, scaled it up to the appropriate chemical manufacturing site, and developed an FDA-approved, cGMP manufacturing protocol for successfully making the critical material-all within a span of approximately 18 months.
As a result of our cooperative efforts, enough material was custom synthesized to satisfy market needs in anticipation of commercial approval. When the new product became commercial shortly thereafter-and thanks to our accelerated project management initiative, our custom synthesis was able to meet demand for the exciting new medical device.