cGMP grade in vivo-jetPEI®

Nucleic acid delivery reagent for clinical trials

  • Nucleic acid delivery reagent for clinical trials in Human
  • Manufactured in compliance with US and EU GMP guidelines
  • Available as bulk powder or sterile liquid formulated product
  • Supported by appropriate manufacturing Quality Controls
  • Supplied with the batch documentation and certification
  • Highly dedicated technical support and strong regulatory compliance expertise

Specifications

Reagent

cGMP grade in vivo-jetPEI®

Molecule delivered

DNA, siRNA, miRNA, Oligonucleotides, mRNA

Applications

Clinical trials in human from phase I to III

Targeted organs

All organs

Injection routes

Systemic injection (intravenous)
Local injection

Amount of reagent

Upon request

Storage

-20 °C, for at least 2 years

Provided with

Quality controls
Batch documentation

Summary

in vivo delivery of nucleic acids represents a novel promising approach for some medical applications such as gene and oligonucleotides therapy. in vivo-jetPEI®, a cationic polymer-based reagent, is a very powerful non-viral vector to safely and easily deliver nucleic acids in vivo, through different routes of administrations. It offers high performance in terms of efficiency, reproducibility and robustness. Nowadays, in vivo-jetPEI® is the most widely used chemical reagent to deliver gene in animals, and was selected as the delivery vector of choice in several drug development programs. For this purpose, Polyplus-transfection® offers a cGMP grade in vivo-jetPEI® which is manufactured in compliance with applicable European Commission (EC) guide to Good Manufacturing Practices (GMP) and FDA requirements for clinical trials phase I to III. This reagent is used worldwide for a growing number of therapies based on nucleic acid delivery.

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Currently used for clinical trials worldwide

in vivo-jetPEI® has been selected as a nucleic acid delivery vector for several drug development programs due to its delivery efficiency. Several phase I and II clinical trials are currently ongoing worldwide using GMP grade in vivo-jetPEI®, mainly for human cancer therapies.
An overview of current non-confidential ongoing trials is provided in the pipeline below (Fig. 1). Preclinical and clinical studies are conducted using GLP or GMP transfection reagents supplied by Polyplus-transfection®, repectively. A full description of these trials is not available due to confidentiality. However, additional information can be obtained on the websites of the clinical trial sponsors.

Fig.1: Clinical pipeline of ongoing clinical trials using <em>in vivo</em>-jetPEI<sup>®</sup>.
Fig.1: Clinical pipeline of ongoing clinical trials using in vivo-jetPEI®.

Manufactured in compliance with US and EU GMP guidelines

cGMP grade in vivo-jetPEI® is qualified to be used in human as this reagent is manufactured in compliance with US (21CFR parts 210 and 211) and EU (Eudralex Volume 4) GMP guidelines by fully accredited GMP subcontractors. Polyplus-transfection® has transferred its expertise to these subcontractors, allowing the use of the same manufacturing process for the cGMP grade reagent as for the non-GMP material.

Available as bulk powder or liquid formulated product

cGMP grade in vivo-jetPEI® can be supplied as a non-formulated, non-sterile lyophilized bulk powder (also called Drug Substance), or as the final sterile product, formulated in aqueous solution (also called Drug Product). In case of Drug Product supply, a customized aseptic Fill and Finish service (formulation, sterilization, aseptic filling…) is performed in a qualified and audited facility.

Supported by Quality Controls and batch documentation

cGMP grade in vivo-jetPEI® is released with a Certificate of Analysis including in process and release Quality Controls and a Certificate of Compliance.
A type II Drug Master File (DMF) is on file with the FDA and can be cross-referenced in IND applications to the US FDA.
For submission of an IMPD to an European Regulatory Agency, Polyplus-transfection® supplies the documentation describing the Chemistry, Manufacturing and Control (CMC) with the purchased GMP batch of in vivo-jetPEI®.

Stability studies provided

Long-term and short-term stability testing data at intended and accelerated storage temperatures as per ICH (International Conference on Harmonization) guidelines are provided with each batch of cGMP grade in vivo-jetPEI®.

Highly dedicated technical support

With a dedicated team for clinical customers having a strong regulatory compliance expertise, Polyplus-transfection® offers the help and support required to accompany your clinical project from R&D through to Investigational New Drug (IND) Application or Investigational Medicinal Product Dossier (IMPD) and from Phase I to Phase III clinical trials.

For any inquiry concerning your project, please contact us.

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