Contracted by the U.S. Defense Department’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), CMC Pharma was tasked with developing and executing a modern current Good Manufacturing Practices (cGMP) stability program that would evaluate whether the drug product could meet specifications once issued to service members for longer than had been previously established. CMC Pharma generated sufficient data through rigorous cGMP testing that was submitted to the FDA to justify the operational shelf-life extension. The FDA-approved drug product will now have an updated label indicating the new 14-month shelf life.
“This is a great example of a program that CMC Pharma designs and executes for both our commercial and government partners,” said Dr. Mike Radomsky, Principal Investigator and President of CMC Pharma. He elaborated, stating “Developing and executing stability studies is just one of our teams’ strengths. As a provider of drug product development lab services, our goal is to help drug developers ensure the safety and efficacy of their portfolio products, whether it is in early research and development or is a commercial, FDA-approved product.”
For this program, CMC Pharma designed and implemented a cGMP stability program that demonstrated that pyridostigmine bromide tablets in a blister pack met stability specifications longer than previously established. The results supported an operational shelf-life extension, enabling the fielded drug product to be utilized longer before needing to be replaced. The shelf-life for this product prior to issue to service members remains the same; however, the ability to keep drug product in the field during the full time that a service member is deployed significantly streamlines logistics for active-duty service members who are issued pyridostigmine bromide tablets.
CMC Pharma has successfully managed a wide variety of pharmaceutical development programs, including multi-year programs with the federal government. For more information about CMC Pharma’s drug product formulation expertise and services, visit www.cmcpharm.com.
Disclaimer: The views and opinions of authors expressed herein do not necessarily reflect those of the United States government and shall not be used for advertising or product endorsement purposes.
About CMC Pharmaceuticals:
CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharma delivers specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development, and consulting services to clients globally. CMC Pharma offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile injectables, solid oral, long-acting, controlled release, and other complex dosage forms.
CONTACT:
Jared Heimovitz, Business Development
CMC Pharmaceuticals
440-637-5865
