Implementing Improved Analytical Methods To Support Vaccine Quality
By Maura C. Kibbey, Ph.D., U.S. Pharmacopeia (USP)
Advancements in analytical technology can improve testing paradigms in vaccine development, while also supporting existing vaccine manufacturing and quality control. A key impediment to implementing new methods for characterizing and releasing licensed vaccines, however, is submitting updates to regulators across multiple jurisdictions. This impediment and perceived regulatory risk can deter manufacturers from adopting new technologies to ensure quality in older products; nonetheless, these tools can be very powerful, bringing efficiencies and better data to help inform decisions and speed new vaccines and therapeutics to patients.