Aldevron case study: validation of mRNA concentration determination using variable pathlength spectroscopy

Wednesday 10:00 PDT / 13:00 EDT / 18:00 BST / 19:00 CEST

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Aldevron case study: validation of mRNA concentration determination using variable pathlength spectroscopy

Traditional cuvette-based UV solutions with fixed pathlengths, such as using a 1cm cuvette, fail to accurately measure and often result in prolonged investigation. Dilution factors and fixed pathlength measurements are unreliable for determining the concentration of a UV chromophore in solution, lacking transferability and robustness for company-wide implementation.

The CTech™ SoloVPE^® spectrophotometer features variable pathlength technology, allowing for automatic adjustment of the optical pathlength from 5µm to 15mm in 5µm increments. This technology allows for determining the appropriate pathlength and achieving linearity even with significantly higher sample concentrations without requiring dilution. The absorbance values obtained are subjected to linear slope regression analysis, with a minimum R2 value of >0.999. Variable Pathlength Technology offers speed, repeatability, and accuracy, making it suitable for global implementation to reduce turnaround time and eliminate the need for multiple personnel waiting for data results before proceeding with the next processing steps.

As Aldevron aims to enhance its analytical testing capabilities to support various product types, it is essential to qualify and validate these new technologies in compliance with regulatory guidelines. This ensures the utmost product quality and patient safety. In this webinar, Aldevron will share their strategy and the results obtained from the platform mRNA content assay, specifically focused on mRNA concentration.

What is Variable Pathlength Technology and how does is differ from traditional UV-vis fixed pathlength spectroscopy

mRNA characterization and regulatory standards for pre-clinical/clinical phases
Method validation for a new analytical procedure/platform
Validation Study results and discussion

Joe Ferraiolo

Director of Bioanalytical Applications, Repligen

Joe is the Associate Director Bioanalytics for Repligen. He is in charge of the Bioanalytics Applications department related to the SoloVPE Variable Pathlength UV solution. He has been with the company for more than 20 years, with over 10 years of development and validation experience in analytical applications. He specializes in UV analysis and leads the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, gene therapy solutions, and monoclonal antibodies.