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Preclinical & clinical Studies: GMP & Qualified Reagents

For pre-clinical use, animal toxicology studies and human clinical studies, in vivo-jetPEI™ and derivatives are available with the appropriate manufacturing quality, documentation and quality controls.

Pre-clinical materials

Qualified in vivo-jetPEI™ and derivatives are available for pre-clinical use, toxicology and stability studies.

  • Available as lyophilized bulk product or formulated final product
  • Custom packaging and formulation available to suit your needs
  • Each batch meets stringent release specifications and is supplied with a complete Certificate of Analysis including in-process and final product quality controls
  • Additional quality controls or assays on request
  • Polyplus provides assistance to design and perform stability programs to support pre-clinical studies

Clinical materials

To support your development of an investigational new drug containing in vivo-jetPEI™ or derivatives, Polyplus is able to supply product manufactured in compliance with applicable EC guide to Good Manufacturing Practices (GMP) and FDA requirements.

Bouteille GMP Lot GMP

  • Polyplus is able to supply Active Substance (non-formulated bulk product) for clinical studies phase I to III
  • In-process and release quality controls are in place as well as specifications for the delivered material
  • The Active Substance is released with an appropriate set of GMP documentation
  • Final Drug Product supply: upon request, Polyplus will arrange and manage the Fill and Finish production (aseptic filling, sterility test, …) with subcontracted partners to supply the Drug Product (finished dosage form)
  • Polyplus may provide assistance during drug development with formulation development programs or stability studies of the reagent
  • The DMF for in vivo-jetPEI™ is on file with the FDA and can be cross-referenced by customers.

With several clinical trials using Polyplus-transfection’s in vivo delivery reagents, the company has acquired a widely-acknowledged expertise in the regulatory and technical issues in this domain. Clinical trials are currently being carried out for cancer therapy (P. Ohana et al., Gene Ther Mol  Biol, 8, 181, 2004; Sidi et al., J Urol., 180, 2008) in Israel and the USA and for HIV immune therapy in Germany and Sweden (J. Lisziewicz et al., J Invest Dermatol 124, 160, 2005).

For more information, please contact the Business Development.