FDA Extends Shelf Life of Medical Countermeasure Through CMC Pharma's Stability Program
Key Insights
CMC Pharma extended the operational shelf life of a medical countermeasure from 3 to 14 months through a stability program.
The FDA approved the extension based on rigorous cGMP testing data provided by CMC Pharma, ensuring longer usability for service members.
Pyridostigmine bromide tablets in blister packs now have an extended operational shelf life, streamlining logistics for active-duty service members.
CMC Pharmaceuticals (search) (CMC Pharma) has successfully extended the operational shelf life of a critical prophylactic medical countermeasure, initially set at three months, to an impressive 14 months. This achievement, contracted by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), ensures that active-duty service members can rely on the medication for a significantly longer period in the field.
Rigorous Stability Testing
CMC Pharma developed and executed a current Good Manufacturing Practices (cGMP) stability program to evaluate the drug product's specifications over an extended duration. The comprehensive testing generated sufficient data to justify the shelf-life extension, which was subsequently approved by the U.S. Food and Drug Administration (FDA). The updated label will reflect the new 14-month shelf life, enhancing logistical efficiency for deployed service members.
Pyridostigmine Bromide Tablets
The program focused on pyridostigmine bromide tablets in blister packs. While the shelf life before issue to service members remains unchanged, the extended operational shelf life means the drug product can be utilized for the entire duration of a service member's deployment, reducing the need for frequent replacements. This streamlining of logistics is a significant benefit for active-duty personnel.
Expert Commentary
"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 further noted, "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."
CMC Pharma's Capabilities
CMC Pharma has a proven track record of managing diverse pharmaceutical development programs, including multi-year collaborations with the federal government. Their expertise encompasses pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, and manufacturing process development.