Validation of mRNA concentration determination using variable pathlength spectroscopy
Analytical testing is a critical factor in the development of mRNA-based therapeutics, while at the same time presenting significant challenges. Pre-clinical and clinical testing are only part of what needs to be included in the development process, with the need to meet regulatory requirements while competing in the marketplace being additional considerations.
As part of a joint case study webinar, Repligen and Aldevron presented, Aldevron case study: Validation of mRNA concentration determination using variable pathlength spectroscopy, where Travis Alvine, Ph.D., Aldevron’s Senior Manager for Analytical Method Validation, joined Joe Ferraiolo, Repligen’s Director of Bioanalytical Applications, to discuss the importance of providing faster and more reliable results as critical solutions for the industry’s analytical challenges.
First, Ferraiolo provided an overview of the CTechTM SoloVPE® spectrophotometer and how it features variable pathlength technology. Then, Alvine discussed how Aldevron aims to enhance its analytical testing capabilities to support various product types, as it is essential to qualify and validate these new technologies in compliance with regulatory guidelines, ensuring product quality and patient safety. Aldevron detailed its strategy and the results obtained from the platform mRNA content assay, specifically focused on mRNA concentration.
In the Q&A portion of the webinar, John Long, Ph.D., Aldevron’s Director of Analytical Method Development, joined Alvine and Ferraiolo to expand on the case study and provide further insight on the process used in the analytical approaches discussed.
You also have the opportunity to download a research article, Validation of mRNA concentration determination by slope spectroscopy technology: a matrixed approach, published in Cell & Gene Therapy Insights, for more in-depth information. We would also like to thank Repligen for the opportunity to share this webinar with our clients.
- Want to learn more? Contact Yasser Kehail for more information
- Visit the mRNA page of our website
- Have a topic to suggest? Let us know