Polyplus-transfection SA has introduced PEIpro-GMP, a transfection reagent designed for the clinical and commercial lentivirus and adeno-associated virus (AAV) production of cell and gene therapies.
The company says PEIpro-GMP provides a solution for a cell and gene therapy industry faced with tightening regulations include around the use of reagents as raw material in the production of viruses for clinical trials, specifically mandating higher levels of quality compliance at earlier stages of clinical development. As a result, industrial viral vector production for cell and gene therapy has to increase in quality, with the essential use of cGMP-compliant raw materials such as plasmids. PEIpro-GMP has been designed as the highest quality grade transfection reagent available on the market compliant with all cGMP viral vector manufacturing requirements.
Transfection reagents are used in lentivirus viral vector production, critical for cell therapies such as CAR-T, and AAV for gene therapy, especially for inherited genetic disorders. The viral vectors are produced using reagents to transiently transfect DNA plasmids into virus producing cell lines such as HEK-293 cells. Following the few days that the virus production process takes, and followed by purification, the viruses are used to infect cells ex vivo for cell therapy or directly injected into humans for gene therapy. The highest grade of Polyplus-transfection’s PEIpro-GMP will enable compliant transfection throughout the clinical and commercialisation processes, the company says.
For further information about Polyplus-transfection visit www.polyplus-transfection.com
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