An Integrated Single-Use Platform for Manufacturing Plasmid DNA (pDNA)

Plasmid DNA (pDNA) plays a critical role in the delivery of gene therapies into targeted cells. The development and delivery of large quantity, high-quality pDNA vectors are in high demand.

Cytovance has developed and integrated Single-use Platform for manufacturing Plasmid DNA (pDNA) using the HyperGRO™ high cell density process that is licensed from Nature Technologies, an industry leader in the field. The fermentation process reduces the risk of recombination events that are common with pDNA containing inverted repeats, such as those associated with Lentiviral Vectors. The fermentation is performed in single use fermenters. The platform purification employs off-the-shelf disposable technologies that ensure a low shear process.

In this webinar, the presenters will describe how the implementation of the imPULSE™ mixer from Thermo Fisher Scientific and the BIA Systems Monolith technologies combine to produce high quality pDNA. In addition to Research Grade and cGMP grade pDNA, Cytovance has worked with its Quality Assurance team to address the industry need for material in between GMP and R&D grade to develop a defined set of Quality standards for Critical Reagent Grade™ pDNA.

Webinar attendees will learn about:

• Cytovance expands its cGMP microbial services to include pDNA
• Cytovance relies on strong regulatory support and QA systems to develop a Critical Reagent Grade™ offering that is suitable as a raw material in any cGMP process
• How integrated single-use systems combine to provide high-quality pDNA