Aug 27 2010
Ricerca Biosciences, a uniquely integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, is pleased to announce the successful completion of the purification of an active pharmaceutical ingredient (API) under current good manufacturing practices (cGMP) controls.
“This process marks a significant milestone for Ricerca as we look forward to the results of this successful development.”
This process was a chiral purification of an API containing four different 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. The recovery of the desired isomer was approximately 90% through the purification process.
Ricerca is able to process under cGMP controls up to 1-2 kg of material with the current configuration of their Prep LC system. Ricerca's Prep LC system is capable of using a prep column with an ID of two inches and is expandable up to four inches (ID) prep columns. This system 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 potential it has for our clients," stated Chairman and CEO of Ricerca Ian Lennox. "This process marks a significant milestone for Ricerca as we look forward to the results of this successful development."
The Prep LC system adds depth to Ricerca's overall platform of capabilities. Utilizing this system is ideal for organizations involved in first time or early phase purification processes.
Ricerca offers a unique spectrum of services for the areas of preclinical discovery and development for biopharmaceutical registration, agrochemical registration and environmental analysis.
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