(Press-News.org) A new report, coauthored by several major pharmaceutical companies, reviews the current state of sterile oligonucleotide drug product processing. The article, which provides recommendations to aid in the evaluation and development of terminal sterilization processes, is published in the peer-reviewed journal Nucleic Acid Therapeutics. Click here to read the article.
All marketed oligonucleotide products are delivered as sterile preparations for parenteral delivery. The two most common methods for sterilizing parenteral drug products are terminal sterilization and membrane sterilization. Terminal sterilization provides greater sterility assurance than membrane sterilization, but not all drug products are amenable to terminal sterilization, which usually involves exposure to high heat or ionizing radiation.
Regarding the terminal sterilization of oligonucleotides, the authors provide recommendations for formulation development, assessing changes in the purity and impurity profile after terminal sterilization, and selecting the correct container closure.
“As the field continues to advance, commercial and academic researchers alike look to Nucleic Acid Therapeutics to provide the community with clear, detailed guidance on candidate therapeutic development and processing,” says Executive Editor Graham C. Parker, PhD, Department of Pediatrics, Wayne State University School of Medicine, 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 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., publishers website.
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Terminal sterilization of oligonucleotide drug products
2023-02-22
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