French company delivers GMP-compliant in vivo-jetPEI for clinical trial
Polyplus-transfection, a company specialised in the research, development and marketing of innovative reagents for transfection and RNA interference (RNAi), has produced the first GMP-quality clinical batch of its nucleic acid transfer agent.
Polyplus-transfection, a company specialised in the research, development and marketing of innovative reagents for transfection and RNA interference (RNAi), has produced the first GMP-quality clinical batch of its nucleic acid transfer agent.
This GMP-compliant in vivo-jetPEI is required for clinical trials involving nucleic acids delivery (DNA and siRNA).
Polyplus-transfection, based in Strasbourg, carried out preliminary work to transfer production to GMP-compliance in 2007 thanks to financial support from the AFM, France's Muscular Dystrophy Association. This has made it possible for a Phase II clinical trial to start in the field of cancer therapy this year, using Polyplus" GMP-compliant in vivo-jetPEI. Details of the clinical trial have not yet been disclosed.
Polyplus-transfection offers its customers the possibility of using the same transfection reagent from the early stages of preclinical research to clinical trials in humans. The in vivo-jetPEI molecule is able to transfect effectively both in vitro and in vivo - which is not the case with most of the commercially available transfection reagents.
A Drug Master File (DMF) describing the manufacturing of in vivo-jetPEI has been filed with the United States Food and Drug Administration (FDA). The DMF provides confidential detailed information about the manufacturing process of the reagent, thus simplifying the FDA documentation required for clinical trial applications.
"We are proud to have delivered this first GMP-compliant batch of in vivo-jetPEI and to have completed the production process transfer," said Joelle Bloch, ceo of Polyplus-transfection. "The GMP-compliant availability of our leading product for human clinical use is a crucial advantage in the choice of a transfection agent for therapeutic projects. It will speed up the growth of all Polyplus' in vivo transfection agents."
The company is "eagerly awaiting" the beginning of this Phase II clinical trial using in vivo-jetPEI that is scheduled for 2008 in the field of anti-cancer therapy."
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 EU.