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An Optimized Platform Process, Upcoming Webinar Hosted by Xtalks

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The platform purification process developed here addresses the main challenges in large scale manufacturing of pDNA such as scalability, quantity and quality.


TORONTO (PRWEB)

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.

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, CytogradeTM and GMP grade for use in gene therapy.

Join expert speakers from Cytovance Biologics, Renija George, Scientist, Upstream Process Development; Ganesh Krishnamoorthy, PhD, Senior Scientist, Downstream Process Development; and Carole Davis, Associate Scientist, Analytical Development, in a live webinar on Thursday, June 24, 2021 at 12pm EDT.

For more information, or to register for this event, visit pDNA Manufacturing: An Optimized Platform Process.

ABOUT XTALKS

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