Oligonucleotide Drug Producers Report on Drug Impurities
Nucleic Acid Therapeutics is an authoritative peer-reviewed journal that focuses on cutting-edge basic research, therapeutic applications, and drug development using nucleic acids or related compounds to alter gene expression. Credit: Mary Ann Liebert, Inc.
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.
This article has been republished from materials provided by Mary Ann Liebert, Inc.. Note: material may have been edited for length and content. For further information, please contact the cited source.
Analytical Tool Predicts Disease-Causing GenesNews
Predicting genes that can cause disease due to the production of truncated or altered proteins that take on a new or different function, rather than those that lose their function, is now possible thanks to an international team of researchers that has developed a new analytical tool to effectively and efficiently predict such candidate genes.
Gene Regulator May Contribute to Protein Pileup in Exfoliation GlaucomaNews
Researchers are seeking factors that contribute to protein pileup in exfoliation glaucomaREAD MORE
Single Gene Change in Gut Bacteria Alters Host MetabolismNews
Scientists have found that deleting a single gene in a particular strain of gut bacteria causes changes in metabolism and reduced weight gain in mice. The research provides an important step towards understanding how the microbiome – the bacteria that live in our body – affects metabolism.READ MORE