Validating a rapid analytical method for DNA purity determination and platform harmonization
Jan
19
2023
On demand

Validating a rapid analytical method for DNA purity determination and platform harmonization

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
Sponsor
Validating a rapid analytical method for DNA purity determination and platform harmonization

Spectrophotometric analysis is one of the most common techniques used to quantify nucleic acids for the production of vaccines or therapeutics. More specifically, the 260/280 UV absorbance ratio of the nucleic acid can be used to determine their purity. However, traditional fixed-pathlength spectrophotometers have limitations when determining the purity ratios of these molecules. Traditional UV-Vis spectrophotometers utilize a fixed 1 cm pathlength and samples most often require sample prep and/or dilution, which ultimately can introduce unnecessary risk and potential for error.

In this webinar, we will share the steps we took to validate the CTech SoloVPE System using the Slope Spectroscopy method for DNA purity determination. The method was evaluated by assessing the specificity, intermediate precision, repeatability, linearity, and accuracy of the theoretical purity ratios. The observed purity ratios from the SoloVPE System demonstrated great comparability with the theoretical purity ratios while eliminating unnecessary risk associated with sample dilution requirements.

  • Introduction to Slope Spectroscopy – a different method for UV-Vis DNA measurement in the production of vaccines and therapeutics
  • Review Design of Experiments (DOE) to validate the SoloVPE System for DNA purity determination
  • Comparison study results to traditional fixed-pathlength spectroscopy
  • How SoloVPE Systems repeatability data can drive platform alignment across various functions and facilities 
Joe Ferraiolo
Joe Ferraiolo
Director, Bioanalytics 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.

SPEAKERS

Joe Ferraiolo
Joe Ferraiolo
Director, Bioanalytics Applications, Repligen

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