Dec
2
2021
On demand

Accelerating Plasmid Production by Optimizing Your Process Analytics

The global demand for plasmid DNA has risen dramatically in the recent years, largely driven by the unprecedented growth in cell and gene therapy. The success in these therapies has increased demand for plasmid DNA used to produce viral vectors, both in quantities for commercial products, as well as for early development programs. In addition, the current situation with COVID-19 has further increased the demand for adenovirus-based or mRNA vaccines, for which pDNA is also the starting material. Unfortunately, scaling up manufacturing capacity for pDNA is complicated and has become a bottleneck for the industry. Plasmid DNA manufacturers that are looking for ways to accelerate production and confirm high quality product are encouraged to sign up for this webinar. We will share a platform process that will eliminate sample dilution and accurately measure DNA purity ratios in less than 5 minutes with an Rvalue accuracy of less than 2% deviation for all 25 sampling percentages. Slope spectroscopy has proven to be a critical analytical method, expediting the testing of challenging samples, providing immediate feedback, and opening up multiple possibilities for meeting your process needs.

  • Understand slope spectroscopy using variable pathlength technology (VPT) and how it's different from traditional fixed pathlength spectroscopy.
  • Discuss strategies to accelerate production by optimizing process analytics for plasmid concentration and purity assessments by reducing time/manpower requirements.
  • Real world experience showing how Pfizer implemented VPT for plasmid DNA purity ratio testing in their human gene therapy product (Pfizer case study)
  • Overview of other gene therapy applications using the SoloVPE System

Paul Mania

Bioanalytics Applications Specialist, Repligen Corporation

Paul Mania is a Bioanalytics Applications Specialist who has been with Repligen Corporation – since 2017. Leveraging his BSc in Biological Science from Duquesne University and industry experience as a laboratory technician, he now helps customers with method validation and implementation – getting solutions integrated and functioning as quickly as possible. Paul enjoys working closely with pharma and biotech companies to assess their current methods and process, understand their specific requirements, and optimize their process development and QC applications to take full advantage of the benefits of Variable Slope UV Spectroscopy.


SPEAKERS

Paul Mania
Bioanalytics Applications Specialist, Bioanaltyics at Repligen Corporation