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Impurity Control Strategies For Therapeutic Peptides

Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate. ....

Mark Strege , Baole Zhang , Julie Zhang , Nikhil Rautela , Mark Kerr , Triptorelin Pamoate , Eli Lilly , Global Biologics Department , United States Pharmacopeial Convention , Pharmacopeial Forum , Expert Committee , Therapeutic Peptides , Quality Risk Management , Mutagenic Impurities , European Pharmacopeiachapter , Listed Drugs , Hybio Pharmaceutical , Standards And Next , Biologics Monographs , Quality Attributes , Synthetic Peptide Drug Substances , Glucagon Bioidentity Tests , Starting Materials , Chemical Synthesis , Gonadorelin Acetate , Ganirelix Acetate ,

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 ,

Implementing Improved Analytical Methods To Support Vaccine Quality

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. ....

United States , Jean Francois Dierick , Francesco Berti , Maurac Kibbey , Earl Zablackis , Dirk Redlich , Van Ooij , Chris Jones , Sanofi Pasteur , Xianzhi Zhou , Sabrina Restrepo , Marta Germano , Sarifa Khan , Mark Van Ooij , Dean Smith , Maura Kibbey , Global Biologics Department , Examples For Vaccine Development , National Institutes Of Health , Vaccine Advisory Group , International Coalition Of Medicines Regulatory Authorities , World Vaccine Congress , World Health Organization As International Reference Standards , International Standards Supporting Vaccine Testing , Expert Panel , Pharmacopeial Forum ,