Stopping the Data Deluge: Enhancing mRNA Drug Development with Digital Solutions
Ever since clinical trials for the first COVID-19 vaccines began in 2020, the demand and development of RNA-based therapeutics have surged. Being safe, efficacious, and disease-specific, RNA-based therapeutics are being developed as vaccines, cancer treatments, and gene therapies. As a result, recent years have seen an increasing trend in RNA-based therapeutic manufacturing, specifically in line with good manufacturing practice (GMP) standards. This surge, however, underlines the need for scalable production processes and robust analytical methods to consistently ensure the safety, potency, and purity of RNA-based therapeutic products.
Handling large datasets during drug development
Production of RNA-based therapeutics relies on important processes such as quantification, screening and analysis of RNA. However, the datasets generated from next-generation sequencing (NGS) libraries and mass spectrometry analysis of mRNA drug substance, as well as quality checks on delivery methods, such as lipid nanoparticle mixtures, can reach enormous sizes. Analyzing this data during the therapeutic development workflow requires specialized scientific expertise. Unfortunately, the sheer scale and complexity of this task can make direct manual analyses nearly impossible. To add to this, the arduous task of managing and organizing vast datasets across multiple development sites can compromise the robustness and scalability of production workflows.
Embracing digital solutions
Automating data capture and associating the captured data with specific batches, assays, and sites, will facilitate streamlined reporting for regulatory filings and can save on a significant amount of time and resources. An integrated biopharma lifecycle management solution, like IDBS Polar—a Biopharma Lifecycle Management Software—can comprehensively track drug candidates throughout their journey from discovery to manufacturing and automate data capture, management, and curation.
Driving smarter and faster decisions
Modern day digital data solutions can help navigate the rapidly evolving landscape of RNA-based therapeutics swiftly. Contact an expert at the Life Sciences companies of Danaher Corporation to know more.