Ricerca Biosciences has completed the purification of an active pharmaceutical ingredient (API) under cGMP controls. The process involved chiral separation of a single API from three chiral isomers. More than 800 grams of material was processed to produce 525 grams of the desired isomer with >99.7% chiral purity and >99% achiral purity.

With the current configuration of the Prep HPLC system, the company is able to process as much as 1-2 kg of material under cGMP controls and the system is expandable to 6-8 kg capacity. It includes an automated fraction collection system to assist in the purification process.

“We are very pleased with the positive outcome of this purification process and the unique potential it has for our clients,” stated Michael Placke, senior vice president and general manager of the Concord, OH site. “This process marks a significant milestone for Ricerca as we continue to expand our capability in response to our client needs. We look forward to the results of this successful development.”