Presentation Abstract
When modifying a comparative agent, blinding strategies often have an impact on the stability of the original product. As a result, a variety of stability testing methods are utilized to ensure that the quality and intended purpose of the comparative agent has not been compromised. Because these tests are often conducted on a competitor’s product, trial sponsors don’t always utilize in-house staff for the required testing. In most cases, external labs are hired to conduct the stability testing. During this session, a speaker from a lab collaborates with an industry client to discuss their working relationship and analyze the required stability testing methods.
About Catalent
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 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com