Synthetic Oligonucleotides Regulatory Analytical Manufacturing Considerations
In early March 2021, more than 300 professionals in regulatory, industry, and academic roles attended the USP's virtual Workshop on Therapeutic Peptides and Oligonucleotides. Building on regulatory considerations and control strategies, the workshop explored innovative techniques being used to analyze synthetic oligonucleotides, ensure quality, and reduce waste.
Synthetic Oligonucleotides Regulatory Analytical Manufacturing Considerations Get more Bioprocess insight with our FREE newsletter sign me up Log In or Subscribe Guest Column | May 28, 2021 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, cardiometabol
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