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The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.
New transfection reagents launched by Polyplus-transfection, a biotechnology company specializing in the delivery of nucleic acids in research, bioproduction, and therapeutics, in December 2018 optimizes cell and gene therapy production to meet regulatory manufacturing compliance and enhances DNA transfection. On Dec. 13, 2018, Polyplus-transfection launched PEIpro-GMP, a transfection reagent designed for clinical and commercial lentivirus and adeno-associated virus (AAV) production of cell and gene therapies. The reagent is a follow up to an earlier product the company launched on Dec. 3, 2018 called jetOPTIMUS, a reagent for nanoparticle DNA transfection.
The increase in regulatory requirements include 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 therapies has to increase in quality. Using cGMP-compliant raw materials such as plasmids becomes a essential. PEIpro-GMP has been designed as the highest quality grade transfection reagent available on the market that is compliant with all cGMP viral vector manufacturing requirements.
Transfection reagents are used in lentivirus viral vector production and are critical for cell therapies such as chimeric antigen receptor T-cell (CAR-T) therapy. AAV for gene therapy is especially essential for targeting 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. PEIpro-GMP will enable compliant transfection throughout the clinical and commercialization processes, the company reports.
The other reagent, jetOPTIMUS, has been designed to enhance mammalian cell transfection and thus maximize gene expression. It is designed to be used primarily for research purposes across academic research in mammalian cells, especially hard-to-transfect cells. The reagent ensures improved cell viability and morphology after transfection for more relevant data, the company reports. This results in the use of minimal reagent volume and DNA quantity, which is expected to considerably decrease cost by up to seven times compared to other market leading products.