Leveraging Next-Generation Sequencing Application from Identity to Purity Profiling of Nucleic Acid-Based Products.

ABSTRACT: Background/Objectives: The nucleic acid-based product (NAP) portfolio is expanding continuously and provides safer curative options for many disease indications. Nucleic acid-based products offer several advantages compared to proteins and virus-based products. They represent an emerging field; thus, their quality control and regulatory landscape is evolving to ensure adequate quality and safety. Next-Generation Sequencing (NGS) is mostly recommended for NAP identity testing, and we are leveraging its application for impurity profiling. Methods: We proposed a workflow for the purity assessment of NAPs through short-read Illumina NGS followed by data analysis of mRNA vaccine and pDNA samples. We determined the sequence identity, DNA and RNA contamination, off-target RNA contam

SUBMITTER: Wadapurkar R 

PROVIDER: S-EPMC11769349 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature