Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, announced the successful completion of the purification of an active pharmaceutical ingredient (API) under current good manufacturing practices (cGMP) controls.
The process involved chiral separation of a single API from three chiral isomers. Over 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, Ricerca is able to readily process up to 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, Ohio, 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."
The Prep HPLC system adds depth to Ricerca's overall platform of capabilities and is ideal for organizations involved in first time or early phase rapid purification processes.
Ricerca offers a unique broad spectrum of services for the areas of preclinical discovery through development for pharmaceutical registration.
Ricerca Biosciences, LLC, offers a comprehensive suite of discovery, preclinical, and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API.