Transfection Reagents for Cell and Gene Therapy

Polysciences offers high-quality, R&D and cGMP grades of transfection reagents for the smooth transition from process development through clinical trials and commercial manufacturing of viral vectors/protein. Polysciences R&D grade PEI MAX has been used by academic and industry customers for over a decade and is one of the most cited transfected reagents. A few years ago Polysciences launched an easy to use liquid version of PEI MAX which is called Transporter 5 focusing on increased customer convenience. Both PEI MAX and Transporter 5 are used in process development. Developing a clinical-grade product according to FDA guidelines involves multiple elements and having cGMP grade raw materials is one of the most crucial one to ensure the safety of the viral therapies and ultimately the patients. Polysciences launched its first GMP transfection reagent in 2019 following US FDA GMP guidelines, 21CFR 210, 211 and 820. We perform quality controls (QCs) in addition to those required by cGMP guidelines according to US pharmacopeia making our MAXgene GMP the only economic transfection reagent that meets highest quality standards for use as a raw material in therapeutic viral vector manufacturing intended for human clinical trials and commercialization. With MAXgene GMP to complete the PEI product range, the transition from process development up to commercialization is a flexible and seamless process as scale up of viral vector production with MAXgene GMP are guaranteed to be comparable to production yields achieved at small scale with R&D grade PEI MAX and Transporter 5 during process development/ preclinical trials.

Polysciences’ produces PEI products with a number of advantages, making them a trusted choice by therapeutics manufacturers for their process development, through clinical trials and commercial manufacturing: