Overview

While the potential benefits of CGT to patients seem clear, the high costs are hard for healthcare systems to carry. A single dose of a treatment can cost millions of dollars which makes access to those therapies very restricted. To be able to reach the full potential of cell and gene therapies in curing diseases, stakeholders need to focus on the ability to manufacture bioproducts concentrated in high quality and efficacious titers. However, viral manufacturing is not simple, with multiple complex challenges ranging from starting material generation, ensuring cellular production of high titers of viral vectors, to purification, where not all viral particles contain the intended genetic payload.

To define optimal conditions for a specific process, we support our customers with a free viral vector DoE (Design of Experiment) service, as part of our scientific support Compared to the, one-factor-at-a-time (OFAT) method, DoE is the most cost-efficient way to design experiments, increase productivity, save time, and tackle the toughest challenges in process development.  

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DOE Service

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Capabilities

Overcome OFAT limits with DoE

Bioproduction of viral vector in eukaryotic cells is critical for cell and gene therapeutics development. This production is known to be a complex process with many involved factors (e.g. nucleic acid concentration) and unit operations (e.g. transfection). To define optimum conditions for a specific process, many scientists refer to the conventional (OFAT) method, which consists of changing one factor at a time while the other elements remain fixed. Design of experiment (DOE) is a multifactorial appraoch that allows faster identification of critical factors and their interactions with a minimal number of experiments to provide a deeper understanding of the process.

Robust optimization : Depth of experience, Professional interpretation, Qualified personal, Open communication

Polyplus® offers its DoE expertise to guide customers into optimizing their process using our transfection reagents. We offer aim to speed up your work by providing experiment design and subsequent analysis. While not being a full process development service based on DoE, this allows you to avoid long and costly material and process transfer, while developing and retaining the experimental know-how.

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Resources

Articles

Improving the Productivity and Packaging Efficiency of AAV Manufacturing Processes via a Process Intensification DoE Approach

Webinars

Upstream AAV production: A Targeted Approach To Optimization
What does Plug-and-Play offer large-scale AAV manufacturing?
Optimization of AAV production for high-yielding and scalable GMP processes

Visuals

FectoVIR®-LV : Ready to use, synthetic and free of any animal-origin component 

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