pDNA Manufacturing: An Optimized Platform Process

The demand for large quantities of high-quality supercoiled plasmid DNA (Sc-pDNA) has increased over the years due to its primary role in gene therapy. Current situation with Covid-19 has further increased the demand for AAV-based or mRNA vaccines, for which pDNA is the starting material. For the upstream process of pDNA, host strain, plasmid design, media composition and fermentation conditions are optimized for high biomass, plasmid yield and quality.

The current optimized upstream process at Cytovance Biologics is scalable to meet these requirements and decrease manufacturing cost. This also facilitates the downstream purification of Sc-pDNA, which is a major bottleneck in large scale pDNA production. Though small-scale purifications of pDNA are well established, purification of pharmaceutical grade pDNA at industrial scale poses several challenges that can impact its final yield and quality.

The platform purification process developed here addresses the main challenges in large scale manufacturing of pDNA such as scalability, quantity and quality. In addition to this, we have developed pDNA analytics that are an important aspect of deciding the success of the manufacturing process.

Quantity, purity, identity, quality and safety of the manufactured pDNA are the characteristics that are determined during analytical testing. The pDNA platform toolbox was created to be a multifaceted approach to analytical testing that is needed to satisfy the product quality attributes required by the U.S Food and Drug Administration (FDA) and World Health Organization (WHO). The plasmid DNA material produced at Cytovance Biologics is available in three different grades: R&D, Cytograde™ and GMP grade for use in gene therapy.

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Speakers

Renija George, Scientist, Upstream Process Development, Cytovance Biologics

Renija is a fermentation scientist and has six years’ experience in Cytovance Biologics. She has performed upstream process transfers and developments with several biologics. She has been responsible for transferring, developing, optimizing and characterizing several upstream processes and has performed DOE (design of Experiment) studies to optimize and characterize the upstream processes. These upstream processes have been successfully transferred and scaled up to cGMP production at large scale. Renija has a Bachelor of Science in Biology and Chemistry from Southern Nazarene University in Oklahoma and a Master of Science in Biomedical Engineering from University of Texas at Dallas.

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Ganesh Krishnamoorthy, PhD, Senior Scientist, Downstream Process Development, Cytovance Biologics

Ganesh is a protein biochemist with a background in pharmaceutical sciences, biochemistry and biotechnology. Ganesh’s areas of expertise include structure-based mechanisms of membrane-bound antibiotic efflux pumps in ESKAPE pathogens, protein purification, process development and scale up-strategies. Ganesh is currently the Senior Scientist, Downstream Process Development at Cytovance Biologics, a CDMO in Oklahoma City. In this role, among other protein purification processes, he has led the development of the integrated single-use platform for plasmid purification. He received a Bachelor of Pharmacy and a Master’s in Science & Technology with Bioprocess Technology Specialization from India and a PhD in Biochemistry from University of Oklahoma. He has more than 15-years’ experience in Protein Biochemistry and Molecular Biology in both Academia and industry and has published more than 12 peer-reviewed research articles and book chapters in leading journals.

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Carole Davis, Associate Scientist, Analytical Development, Cytovance Biologics

Carol has six years’ experience with Cytovance Biologics and over 12 years of experience working in academia with a focus on oncology. Her experience is with multiple biologics including monoclonal antibodies, growth factors, enzymes, pDNA and other therapeutics. Carole currently works in the Analytical Development division of R&D at Cytovance Biologics. She has been responsible for developing, transferring, optimizing, qualifying and evaluating numerous analytical methods for in-process, release and characterization testing. These methods have been successfully transferred to internal and external quality control laboratories. Carole has a Bachelor of Science in Microbiology from the University of Oklahoma and a Master of Forensic Science from the University of Central Oklahoma.

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