Bioanalytical assays for oligonucleotide therapeutics

A new article in the peer-reviewed journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration that immunogenicity assays may be necessary to measure immune responses to different components of oligonucleotide therapeutic (ONT) drugs, especially when the therapeutic includes carriers or conjugates. Click here to read the article.

A recent FDA guidance calls for better analytical tools to evaluate the drug metabolism and pharmacokinetics of ONTs and more broadly evaluate their absorption, distribution, metabolism, excretion, and toxicology properties.

Carl Ascoli, from Rockland Immunochemicals, and coauthors, state that, “Optimal methods for sample analyses should consider the advantages, disadvantages, and limitations of each assay, differences in the matrix (e.g., plasma, tissue, or urine), the sensitivity of detection required as well as the objectives for the analysis (quantitative PK measurement or qualitative metabolite identification).”

The authors propose that “highly specific antibodies to ONT modifications and the immunoassays they enable may potentially enhance the development and production of ONTs, expand studies to determine the safety and efficacy of this class of drugs, and serve as orthogonal assays to supplement data collected using established assays for the analysis of ONTs.”

“Nucleic Acid Therapeutics welcomes this fine addition to the armatorium of bioanalytical assays needed to identify successful candidate oligonucleotide-based drugs for further development, and welcomes efforts to validate this approach,” 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., a Sage Company, is known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s more than 100 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., website.