GMP in vivo-jetPEI®
DNA, siRNA, miRNA, Oligonucleotides
Human Clinical trials Phase I to commercialization (cancer therapy, vaccination), Gene Therapy
Various systemic and local administration routes
|Amount of reagent|
-20 °C, for at least 2 years
Certificate of Analysis (CoA), Certificate of Compliance (CoC), Material safety data sheet (MSDS), Drug Master File (DMF) on file at the FDA, Chemistry, manufacturing and controls documentation (CMC), Quality agreement
in vivo delivery of nucleic acids represents a novel promising approach in the fight against genetic and hereditary diseases, viral infections, and cancer. GMP in vivo-jetPEI® is the leading chemical-based non-viral delivery reagent that is used for direct injection of therapeutic nucleic acids (Gene Therapy).
Table 1: Range of in vivo-jetPEI® quality grade reagents for each step of nucleic acid-mediated non-viral vector-based manufacturing. in vivo-jetPEI® is available as an R&D grade for fundamental research and proof of concept studies. For preclinical biodistribution and toxicology studies and early phase clinical studies, we supply a higher preclinical grade in vivo-jetPEI®. GMP in vivo-jetPEI® is the highest quality grade available to meet quality demands in Human clinical trials.
Approved excipient for nucleic acid delivery in Human
GMP in vivo-jetPEI® is the non viral delivery vector used in several nucleic acid-based drug development programs worldwide. A list of non-confidential ongoing clinical trials is provided in the pipeline chart below (Fig.1), with a majority of gene therapy clinical trials for cancer treatment. A full description of these clinical trials is not provided due to confidentiality agreements. Further information is available on clinical trial sponsors’ websites.
Figure 1. in vivo-jetPEI®, a reagent of choice for therapeutic applications. in vivo-jetPEI® has been selected as a nucleic acid delivery vector for the development of a growing number of nucleic acid-mediated therapie. Type of nucleic acid delivered, administration route and therapeutic application are very diverse.
📰 Read more on Anchiano Therapeutics’ Success Story: “Supporting Bladder Cancer Gene Therapy: Polyplus-transfection® SA at the Forefront with Anchiano Therapeutics“. Anchiano Therapeutics’ pivotal phase II study with lead product candidate inodiftagene vixteplasmid started in December 2018. We received this announcement with great excitement at Polyplus-transfection® SA: the nucleic acid delivery vector used to target bladder cancer cells with Inodiftagene is none other than in vivo-jetPEI® transfection reagent…
GMP manufacturing process
Manufactured in compliance with US and EU GMP guidelines
GMP grade in vivo-jetPEI® is manufactured by fully accredited GMP subcontractor and qualified to be used as an excipient for nucleic acid delivery in Human patients. Polyplus-transfection® has transferred its expertise to fully accredited GMP subcontractors to ensure consistent manufacturing process between GMP grade reagent GMP in vivo-jetPEI® and non-GMP grade in vivo-jetPEI® and in vivo-jetPEI®-PC.
Excipient available as non-formulated bulk powder or sterile liquid formulated product
Figure 2. Manufacturing process from starting material to final drug product
GMP grade in vivo-jetPEI® can be supplied as a non-formulated lyophilized bulk powder or as a ready to use sterile product, formulated in aqueous solution. In case of liquid product supply, a customized aseptic Fill and Finish service (formulation, sterilization, aseptic filling…) is performed in a qualified and audited facility.
Expert Clinical and Regulatory Support
Do you need more insight on current regulation for market authorization? With more than 25 years of combined experience in the development and manufacturing of GMP compliant transfection reagent for Cell and Gene Therapy, our Clinical and Regulatory Support Team is there to accompany each of you by offering regulatory expertise.
We offer regulatory support for your IND applications to the US FDA and for submission to any European Regulatory Agency with:
- Drug Master File (DMF) on file with the US FDA that can be cross-referenced in IND applications and BLA (Biological License Application) to the US FDA.
- documentation describing the Chemistry, Manufacturing and Control (CMC) for IMPD submission or Marketing Authorization to any European Regulatory Agency.
Buscail, L., Bournet, B., Vernejoul, F., Cambois, G., Lulka, H., Hanoun, N., Dufresne, M., Meulle, A., Vignolle-Vidoni, A., Ligat, L., Saint-Laurent, N., Pont, F., Dejean, S., Gayral, M., Martins, F., Torrisani, J., Barbey, O., Gross, F., Guimbaud, R., Otal, P., Lopez, F., Tiraby, G., Cordelier, P. (2015). First-in-man phase 1 clinical trial of gene therapy for advanced pancreatic cancer: safety, biodistribution, and preliminary clinical findings. Mol Ther. 23(4), 779-89.
Matouk, I., Raveh, E., Ohana, P., Lail, R.A., Gershtain, E., Gilon, M., De Groot, N., Czerniak, A., Hochberg, A. (2013). The increasing complexity of the oncofetal h19 gene locus: functional dissection and therapeutic intervention. Int J Mol Sci. 14, 4298-316.
Taljaard M., Ward M.R., Kutryk M.J., Courtman D.W., Camack N.J., Goodman S.G., Parker T.G., Dick A.J., Galipeau J., Stewart D.J. (2010). Rationale and design of Enhanced Angiogenic Cell Therapy in Acute Myocardial Infarction (ENACT-AMI): the first randomized placebo-controlled trial of enhanced progenitor cell therapy for acute myocardial infarction. Am Heart J. 159(3), 354-60.
Sidi, A. A., Ohana, P., Benjamin, S., Shalev, M., Ransom, J. H., Lamm, D., Hochberg, A., Leibovitch, I. (2008). Phase I/II marker lesion study of intravesical BC-819 DNA plasmid in H19 over expressing superficial bladder cancer refractory to bacillus Calmette-Guerin. J Urol. 180(6), 2379-83.
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