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 leads the bioanalytics applications team and is in charge of the SoloVPE variable pathlength spectroscopy system for at-line applications. He has been with the company for more than 20 years, with over ten 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 biologics.

Travis Alvine

Senior Manager, Analytical Method Validation, Aldevron

Travis leads the analytical method validation group and manages analytical method validation, method transfer, and method implementation into the Quality Control release laboratory at Aldevron’s Fargo location. He has been with Aldevron for over 6 years, with experience in analytical method development and validation over that time.

John Long

Director, Analytical Method Development, Aldevron

John Long has over 20 years of experience working in analytical methods for large molecule therapeutics including Vaccines, Biologics, and Gene Therapy products. He has experience across the analytical life cycle including method development, validations, and transfers worldwide. John has supported products from early development through licensure as well as support for marketed products. He has broad experience in compliance, investigations, inspections, and regulatory submissions.

Watch now

SPEAKERS

Joe Ferraiolo

Director of Bioanalytical Applications, Repligen

Travis Alvine

Senior Manager, Analytical Method Validation, Aldevron

John Long

Director, Analytical Method Development, Aldevron

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