Oligonucleotide drug producers coauthor report on drug impurities


Credit: Mary Ann Liebert, Inc., publishers

New Rochelle, NY, December 12, 2017–A new addition to a series of articles that focus on important topics related to the development of oligonucleotide therapeutics presents an in-depth look at the identification, characterization, and reporting of product-related impurities. The article entitled "Impurities in Oligonucleotide Drug Substances and Drug Products," which covers both the chemistry and safety aspects of impurities and provides scientific advice on impurity qualification requirements, is published in Nucleic Acid Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Nucleic Acid Therapeutics website.

Daniel Capaldi, Ionis Pharmaceuticals, and coauthors from AstraZeneca, ProQR Therapeutics, Alnylam Pharmaceuticals, Anavex Life Sciences, GlaxoSmithKline, ISA Therapeutics, and Celgene catalogued the oligonucleotide impurities reported in the scientific literature and broadly grouped them based on structure. Based on their experience, they have found that efforts to characterize impurities in these substances often lead to process improvements in drug synthesis and ultimately higher purity drug products. Furthermore, the similarities among oligonucleotide therapeutics and their methods of synthesis increase the likelihood that information gained from studying one drug substance can be applied to another.

"For advances to happen, regulatory agencies, funding sources, and therapeutic oligonucleotide developers alike need to be able to understand the progress, and the remaining concerns. The clarity and candor of this much-needed multi-stakeholder white paper on the impurities associated with oligonucleotide therapeutic production adds a vital discussion to our ongoing series of white papers," says Executive Editor Graham C. Parker, PhD, The Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Children's Hospital of Michigan, Detroit, MI.


About the Journal

Nucleic Acid Therapeutics is an authoritative peer-reviewed journal published bimonthly in print and online that focuses on cutting-edge basic research, therapeutic applications, and drug development using nucleic acids or related compounds to alter gene expression. The Journal is under the editorial leadership of Co-Editors-in-Chief Bruce A. Sullenger, PhD, Duke Translational Research Institute, Duke University Medical Center and Annemieke Aartsma-Rus, PhD, Leiden University Medical Center, and Executive Editor Graham C. Parker, PhD. Nucleic Acid Therapeutics is the official journal of the Oligonucleotide Therapeutics Society. Complete tables of content and a sample issue may be viewed on the Nucleic Acid Therapeutics website.

About the Society

The Oligonucleotide Therapeutics Society is an open, non-profit forum to foster academia- and industry-based research and development of oligonucleotide therapeutics. The society brings together the expertise from different angles of oligonucleotide research to create synergies and to bring the field of oligonucleotides to its full therapeutic potential.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Human Gene Therapy, Assay and Drug Development Technologies, Applied In Vitro Toxicology, and DNA and Cell Biology. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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Phone: (914) 740-2100 (800) M-LIEBERT Fax: (914) 740-2101

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Original Source

http://www.liebertpub.com/global/pressrelease/oligonucleotide-drug-producers-coauthor-report-on-drug-impurities-in-nucleic-acid-therapeutics/2307/ http://dx.doi.org/10.1089/nat.2017.0691