Preclinical and Cell Therapy reagents

Nucleic acid delivery reagents

  • For Pharmacology, Biodistribution and Toxicology Preclinical studies or for Cell Therapy
  • Manufactured with stringent release specifications
  • Supported by appropriate and customized manufacturing Quality Controls
  • Supplied with a Certificate of Analysis including in-process and final product Quality Controls
  • Custom packaging and formulation available
  • Robust and long shelf life
  • Highly dedicated technical support

Specifications

Reagents

in vivo-jetPEI®, jetPEI® and their derivatives

Molecule delivered

DNA, siRNA, miRNA, Oligonucleotides, mRNA

Applications

Preclinical studies
Cell Therapy trials

Targeted organs

All organs/cell types

Injection routes

Systemic injection (intravenous)
Local injection

Amount of reagent

Upon request

Storage

-20 °C, for at least 2 years

Provided with

Certificate of Analysis

Summary

Preclinical studies are a prerequisite to an IND or an IMPD submission to assess mainly safety but also performance of a new drug. They usually encompass pharmacodynamics and toxicology studies but also biodistribution and pharmacokinetics. The FDA requires researchers to use Good Laboratory Practices (GLP) for preclinical laboratory studies.
For GLP preclinical studies requiring the delivery of nucleic acids, Polyplus-transfection® supplies preclinical grade reagents that meet all the criteria for such studies.
Polyplus-transfection® reagents are also perfectly suited for Cell Therapy Trials requiring a transfection step. Indeed, our reagents are manufactured in accordance with requirements for raw materials in Advanced Therapy Medicinal Product manufacturing for the generation of enhanced/modified cells.

Currently used for clinical trials worldwide

in vivo-jetPEI® has been selected as a delivery vector for several drug development programs due to its delivery efficiency. There are currently several ongoing preclinical studies and phase I and II clinical trials, mainly for cancer therapies, using in vivo-jetPEI® (Fig. 1).
Moreover, as an example of the use of Polyplus’ transfection® reagents in a Cell Therapy trial, a clinical trial for Enhanced Angiogenic Cell Therapy following Acute Myocardial Infarction using jetPEI®-Macrophage, approved by Health Canada, is currently ongoing at Ottawa Research Hospital Institute (Ottawa).

Fig.1: Clinical pipeline of ongoing preclinical and clinical trials using in vivo-jetPEI®.

Stringent release specifications

With years of extensive expertise, Polyplus-transfection® has a well-established manufacturing process, allowing the supply of remarkably high quality reagents meeting very stringent release specifications. These reagents are manufactured in compliance with Good Laboratory Practices (GLP) and are suitable for the use in preclinical studies. They can also be used as raw materials for Cell Therapy and Regenerative Medicine trials.

Appropriate manufacturing Quality Controls

Preclinical grade reagents and reagents dedicated to Cell Therapy trials are released with a Certificate of Analysis including in process and final product Quality Controls for sterility, mycoplasma and endotoxin testing.
Additional Quality Controls or assays are available upon request to fulfill specific needs of our customers.

Custom packaging and formulation

A fully customized aseptic Fill and Finish service (formulation, sterilization, aseptic filling…) is offered upon request with all preclinical grade reagents, as well as for reagents used as raw materials in Cell Therapy trials.

Stability of the reagents

Polyplus-transfection®’s reagents have a robust and long shelf life of a minimum of two years, ideal for timely completion of preclinical or cell therapy studies. Stability study programs as well as retain of material for retests are available upon request.

Highly dedicated technical support

With a dedicated team for preclinical and clinical customers, 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.

Ohana, P., Gofrit, O., Ayesh, S., Al-Sharef, W., Mizrahi, A., Birman, T., Schneider, T., Matouk, I., de Groot, N., Tavdy, E., Sidi, A.A., Hochberg, A. (2004). Regulatory sequences of the H19 gene in DNA based therapy of bladder cancer. Gene Therapy and Molecular Biology 8, 181-1.

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. 2010 Mar;159(3):354-60.