Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations
By Maura Kibbey, Ph.D., and Nick Healy, U.S. Pharmacopeia (USP)
After decades of investment, research, and development, the therapeutic value of oligonucleotides has started to materialize. Dozens of developers now have dedicated pipelines for diverse indications such as oncology, central nervous system diseases, cardiometabolic disorders, liver diseases, and viral infections, including COVID-19. A search for “oligonucleotide” on ClinicalTrials.gov returned more than 50 active studies. Advances in analytical methods are helping to support these pipelines.
Across the development and release landscapes, methods continue to refine, streamline, and support the development of oligonucleotides from new applications of nuclear magnetic resonance (NMR) spectroscopy that are pushing the boundaries of what can be accomplished in development, to innovative platform approaches for specification and release t
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.