The new GMP conditioning product offering is designed to support clinical phase and commercialization stages of cell and gene therapy production.
Polyplus-transfection, a French biotechnology company specializing in innovative transfection solutions for gene and cell therapy production, now has a GMP-grade transfection reagent, PEIpro-GMP, in additional conditioning that will ensure added flexibility and cost-efficiency in the manufacture of cell and gene therapies. The company launched the new product on Dec. 3, 2019.
Polyplus-transfection commercialized PEIpro-GMP at the end of 2018, touting it as the first transfection solution for the gene and cell therapy industry that is compliant with global cGMP viral-vector manufacturing requirements. The company is now expanding the PEIpro-GMP packaging options from a 1-L single-use bag to several conditioning options from 10 mL 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, according to the company. Polyplus-transfection is now providing two sizes of PEIpro-GMP in bags to ensure aseptic connections to successfully perform large-scale transfection in closed sterile systems. The company 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 company stated. 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, in a company press release. “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.”