Catalent Principal Scientists to Present at Method Validation Conference
Research Triangle Park, NC, July 23, 2010
– Corinne Mounier-Lee, Ph.D., Principal Scientist at Catalent Pharma Solutions, will deliver a presentation titled “Enhancing Analytical Quality Through the Use of UPLC: One Method in Place of Two” at CBI/IVT’s 7th Annual Method Validation Conference, July 28-30, 2010 in San Francisco, CA. The three-day conference is designed for those who manage or execute the validation of analytical methods for the quality control of small and large molecule pharmaceuticals, biopharmaceuticals and biologics.
Dr. Mounier-Lee will detail how a UPLC method was developed and validated for simultaneous quantitation of related substances in a combination drug product containing two active pharmaceutical ingredients (APIs). The method was then shown to separate the four known degradation products as well as API-related impurities and unknown related substances. This enhanced UPLC method allows for more reliable and efficient testing of the product relative to the current state in which testing was conducted via two separate HPLC methods.
Dr. Mounier-Lee received her B.S. in Chemistry from the Ecole Supérieure de Chimie Industrielle de Lyon, France, and her Ph.D. in Chemistry from Emory University in Atlanta, Georgia, USA, followed by a NIH postdoctoral research position at the Georgia Institute of Technology in Atlanta, Georgia, USA. She specializes in liquid chromatography, high-pressure liquid chromatography, gas chromatography, headspace analysis, and dissolution testing.
For more information on Catalent’s broad range of biopharmaceutical development, go to www.catalent.com/development .
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,000 people at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion in annual revenue. For more information, visit www.catalent.com .