Navigating mRNA Process Development

Demand for and development of RNA-based therapeutic technology has accelerated since clinical trials for the first COVID-19 vaccines began in 2020. RNA-based therapeutics offer solutions for various applications, including vaccines, cancer, and gene therapies. Consequently, there has been an increased demand for RNA manufacturing, especially to Good Manufacturing Practice (GMP) standards. This surge underlines the need for scalable production processes and robust analytical methods to ensure the safety, potency, and purity of RNA drug product.

However, achieving these goals can be challenging due to multiple hurdles in the RNA production workflow. These difficulties range from supply chain instabilities that extend development timelines to ensuring RNA Critical Quality Attributes (CQAs), such as 5’- capping and Poly A tail degradation, to time-consuming tasks of end-to-end data curation, tracking, traceability, and manual data processing.

The Life Sciences of Danaher understands these complexities and brings solutions in automation, analytics, and digitization. This provides an integrated approach for mRNA process development. These analytical capabilities, such as SCIEX instruments—including the ZenoTOF 7600 System, a high-resolution mass spectrometer, and the BioPhase 8800 System, a multi-capillary electrophoresis system—deliver rigorous and time-efficient analyses of RNA CQAs, ensuring product safety and efficacy.

In addition to precise analytical tools, there is a crucial need for the highest quality raw materials in RNA manufacturing. Through Aldevron's manufacturing and development services, we provide starting plasmid and enzymes and custom manufacturing solutions for mRNA drug products. This includes in-house In Vitro Transcription (IVT) enzyme optimization, analytical methods, testing, and drug substance encapsulation into lipid nanoparticles. This comprehensive approach can accelerate the preclinical or GMP RNA drug product manufacturing timeline and deliver transformative mRNA solutions to the market more swiftly and efficiently.

The Life Sciences companies of Danaher offer comprehensive, adaptable, and customizable solutions for mRNA workflows. These solutions ensure a seamless transition from small-scale bench-top processes to large-scale commercial production while guaranteeing the highest quality and efficiency of mRNA drug product. Get in touch with an expert. We’ll help you get to your next breakthrough.