GMP-Compliant Nucleic Acid Transfer Agent Produced by Polyplus-transfection
Polyplus-transfection (New York, NY), has announced the production of its transfection reagent in vivo-jetPEI, manufactured in full compliance with good manufacturing practices (GMPs).
Polyplus-transfection (New York, NY), has announced the production of its transfection reagent in vivo-jetPEI, manufactured in full compliance with good manufacturing practices (GMPs). This GMP-compliant in vivo-jetPEI is required for clinical trials involving the delivery of nucleic acids (DNA and siRNA).
The in vivo-jetPEI molecule is able to transfect effectively both in vitro and in vivo, which is not the case with most commercially available transfection reagents.
A Drug Master File (DMF) describing the manufacturing of in vivo-jetPEI has been filed with the US Food and Drug Administration (FDA). The DMF provides confidential detailed information about the manufacturing process of the reagent, simplifying the FDA documentation required for clinical trial applications.
The development of the in vivo-jetPEI GMP-compliant process has required the design of new quality control tests to meet the current requirements in the US and the European Union.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
