in vivo-jetPEI® and derivatives are available from Polyplus-transfection for pre-clinical use, toxicological studies in animal and human clinical trials. For these applications, the products are supported by the appropriate manufacturing quality controls, full documentation and certification.
Polyplus-transfection is able to supply batches of in vivo-jetPEI® for all preclinical studies including GLP (Good Laboratory Practice) toxicology support.
- Preclinical batches are available in volumes from 50 mL to multiple liters
- Custom packaging and formulation are available to suit all your needs – including filling in sealed glass vials
- Each GLP 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 are available on request
- Polyplus is able to assist in the design and performance of stability programs to support pre-clinical studies
Clinical Drug Substance and Drug Product
To support development of your Investigational New Drug (IND) or an Investigational Medicinal Product (IMP) containing in vivo-jetPEI® or derivatives, Polyplus is able to supply batches of drug substance and drug product manufactured in compliance with applicable European Commission (EC) guide to Good Manufacturing Practices (GMP) and FDA requirements.
- Polyplus supplies either the bulk Active Drug Substance (non-formulated bulk product) or the Final Drug Product (sterile liquid formulated product)
- GMP batches are available for clinical studies phase I to III inclusive
- In-process and release quality controls are in place in combination with full specifications for the drug substance/product
- Polyplus manages the Aseptic Fill and Finish step (formulation, sterilization, aseptic filling, etc) for the preparation of the Final Drug Product according to your specific needs. Fill and Finish is performed by a qualified and audited sub-contractor. Custom filling volumes and packaging are available on request.
- Long-term and short-term stability testing data at intended and accelerated storage temperatures as per ICH (International Conference on Harmonization) guidelines can be designed and managed by Polyplus.
- A type II Drug Master File (DMF) entitled “in vivo-jetPEI®, Non-sterile Bulk Drug Substance” is on file with the FDA and can be cross-referenced by when submitting IND’s to the US FDA.
- With GMP batches, Polyplus provides all the information related to the manufacturing procedures and controls for finished dosage forms (Final Drug Product) to customers to be included in the IND or clinical applications.
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).
The use of polyethylenimine (PEI) or polypropylenimine (PPI) or cationic polymers similar in structure thereto for transfecting cells, as well as compositions comprising these cationic polymers and at least one nucleic acid, are the subject matter of U.S. Patent No. 6,013,240, EP Patent No. 0770140 and foreign equivalents, for which Polyplus-transfection® is the worldwide exclusive licensee.