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Therapeutic Oligonucleotides Regulations Quality Standards

Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders,. ....

Delaine Fowler , Kui Yang , Hagen Cramer , Giovanni Calderisi , Dennis Rhodes , Saritak Acharya , Philip Ross , Deyi Zhang , Andrew Argo , Christian Zeine , International Council For Harmonization , Global Biologics Department , Oligonucleotide Safety Working Group , Office Of Generic Drugs , Janssen Pharmaceuticals , European Medicines Agency , Wave Life Sciences , Quality Standards , International Council , Generic Drugs , Drug Evaluation , Chemico Biological Interactions ,

Synthetic Oligonucleotides Regulatory Analytical Manufacturing Considerations

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 a ....

United States , Alfred Ross , Chong Jiang , Nadim Akhtar , Yogesh Sanghvi , Michael Bartlett , Nick Healy , Brian Rivera , Nicholas Healy , Maura Kibbey , Johns Hopkins University , Standards Division , Global Biologics Department , National Institutes Of Health , Towson University , Oligonucleotides Expert Committee , University Of Georgia College Pharmacy , Council Of Experts , European Medicines Agency , While The Oligonucleotide Safety Working Group , Therapeutic Peptides , Expert Volunteers , Oligonucleotides Expert , Oligonucleotide Safety Working Group , Georgia College , Rev Drug ,