Process Development

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VGXI’s process development team has the expertise to handle your most challenging projects.

Every plasmid is different and varying parameters can affect yield and quality. We believe it is critical that these parameters be optimized prior to the onset of a project.

That is why we will work with you to define the critical stability and quality specifications for your unique plasmid.

Process Development Project

Our process development projects include the following:

Cell Bank Optimization

The process development lab evaluates a series of cell lines for the specific product and screens a number of colonies to generate a high quality cell bank. The transformation and cell banking processes may be conducted in the GMP plant with evaluations performed in the research facilities. Therefore, GMP and research cell banks can be produced from the same origin.

Fermentation Optimization

A series of 10 L fermentation runs are conducted under various growth conditions. Biomass, yield and quality are evaluated and assessed to maximize productivity and quality for downstream applications.

Purification Optimization

Small-scale research purification studies are performed using the same methods as large-scale purification. We optimize conditions based on the size and characteristics of the product. Quality Control performs a series of stringent evaluation assays on the final product which, once approved, is delivered to the customer.

Did you know?Did you know?  VGXI’s process development team is also available to work on stand-alone projects?

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Residual Kanamycin in the VGXI Process

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