StemCell Therapy

New GMP conditioning of PEIpro-GMP designed to support clinical phase and commercialization stages of production

Strasbourg, France December 3, 2019 Polyplus-transfection(R) SA, the leading biotechnology company that supports gene and cell therapy by supplying innovative transfection solutions, today announces the availability of the first GMP-grade transfection reagent PEIpro(R)-GMP in additional conditioning that will ensure additional flexibility and cost-efficiency.

Polyplus-transfection commercialized PEIpro-GMP at the end of 2018. This was the first transfection solution for the gene and cell therapy industry that is compliant with global cGMP viral vector manufacturing requirements. Polyplus-transfection is now expanding the PEIpro-GMP packaging options from a 1 liter single-use bag to several conditioning options from 10 milliliters up to 1 liter in both single-use bags and bottles.

The use of closed-systems and single-use technologies for clinical trials and commercial manufacturing of viral vectors continues to increase. Polyplus-transfection is now providing two sizes of PEIpro-GMP in bags to ensure aseptic connections to successful perform large-scale transfection in closed sterile systems. Polyplus-transfection now additionally supplies PEIpro-GMP in bottle conditioning that will allow the adaption to different manufacturing scale-up and scale-out strategies. These increasing scale-out strategies require the performance of multiple smaller-scale transfections in multiple cell culture units at the same time. Demand for transfection reagents has thus increased for the smaller as well as for the larger conditioning options. The increases in options will therefore result in additional flexibility for therapeutic developers in the setup of cost-efficient viral vector manufacturing processes.

Polyplus-transfection has been developing strong supplier-manufacturer relationships over eighteen years, and certainly since the conception of the modern gene and cell therapy industries. As a result, we have unrivalled first hand visibility on the ever-changing needs of the gene and cell therapy markets, said Claire Wartel, PhD, director of quality and compliance, Polyplus-transfection. The focus of the market has evolved to commercialization and late-stage clinical stages. This means the therapeutic production scale and strategy needs to be adaptable to the production of each viral vector, whilst complying with cGMP manufacturing requirements. To provide this critical function in making available therapies to patients, Polyplus-technology is now able to offer a sustainable solution for viral vector platforms. This will benefit gene and cell therapy developers, the wider industry, and most importantly, the patient community reliant on the ongoing development of these therapies.

Claire Wartel recently gave more information on Identifying and mitigating risks in the viral vector supply chain in a podcast interview that can be accessed here.

About Polyplus-transfection SA

Polyplus-transfection SA is a biotechnology company specializing in nucleic acid delivery solutions located close to the University of Strasbourg in Eastern France and a market leader for transfection reagents for cell & gene therapy. Polyplus-transfections vast portfolio of delivery solutions can be used for all types of applications, from research and process development, all the way to clinical trials. For more information, please visit the Polyplus-transfection web site at: http://www.polyplus-transfection.com.

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Polyplus-transfection expands GMP portfolio to deliver flexibility for gene and cell therapy manufacturing - BioSpace

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