The highest quality grade for therapeutic virus production
- GMP-compliant raw material for Human Advanced Therapy Medicinal Product (ATMP)
- Bags with MPC connectors and weldable tubing for ease of use in closed systems
- Guaranteed virus production yields equivalent to PEIpro® or PEIpro®-HQ
- Ease your risk management process
- Rely on our Expert Regulatory support team
Plasmid DNA and co-delivery of several plasmid DNA
Large scale virus production for clinical trials and commercialization
Mainly adenovirus, Adeno-Associated Viruses (AAV), Lentiviral Vector (LV), influenza virus, retrovirus, Virus-Like Particles (VLP)
Mammalian producer cell lines (HEK-293, HEK-293 derivatives, BHK, VERO cell lines, virus-specific packaging cell lines) grown in adherent or suspension cultures
|Number of transfections|
1 L of PEIpro®-GMP is sufficient to transfect on average 500 L of cell culture
5 ± 3°C, 2 years from manufacturing date
Certificate of Analysis
|Regulatory documentation available upon request|
DMF (Drug Master File) on file (FDA)
PEIpro®-GMP is the highest quality grade PEI and the only transfection reagent available on the market supplied in a bag with MPC connectors and weldable tubing, ideal for GMP-compliant closed system manufacturing of clinical grade therapeutic viral vector, such as AAV and lentivirus. Large-scale transfection protocols established with PEIpro® or PEIpro®-HQ are guaranteed to be seamlessly applicable with PEIpro®-GMP for manufacturing of therapeutic viral vectors for late phase clinical trials to commercialization.
PEIpro®-GMP is manufactured in compliance with EU “Guidelines for good manufacturing practices for medicinal products for human and veterinary use” (ICH Q7 and Eudralex Vol 4, Part II, Annex I) and is therefore perfectly suitable as raw material for production of therapeutic viral vectors (eg. AAV, lentivirus) for clinical trials and commercialization.
|Reference Number||Amount of reagent|
PEIpro®-GMP manufacturing process
PEIpro®-GMP is manufactured according to a validated manufacturing process in compliance with GMP guidelines to ensure traceability from starting material to the final product. GMP guidelines for manufacturing of ATMP requires that raw materials be of pharmaceutical grade when available (ICH Q7 and Eudralex Vol 4, Part II, Annex I). To address this requirement, both steps of PEIpro®-GMP manufacturing (chemical product and fill & finish) are managed in compliance with GMP guidelines in GMP accredited facilities (Fig. 1). The full list of Quality Controls assessing Identity, Potency, Purity and Safety performed according to European Pharmacopeia is available upon request.
The validated manufacturing process of PEIpro®-GMP allows Polyplus-transfection to obtain an amazing lot-to-lot reproducibility:
Guaranteed seamless transition from clinical trials to commercialization of viral therapies
PEIpro®-GMP is the highest quality grade PEI transfection reagent for use as raw material in the production of viral vectors (eg. AAV, lentivirus) intended for Human ATMP clinical trials and commercialization. With PEIpro®-GMP to complete the PEIpro® product range, the transition from process development up to commercialization is a straightforward seamless process. To ensure validation process for commercialization, scale-up of therapeutic virus production with PEIpro®-GMP are guaranteed to be comparable to production yields achieved at lower production scale during PD with R&D grade PEIpro® and during preclinical and early clinical trials with PEIpro®-HQ.
PEIpro®-GMP bags with MPC connectors and weldable tubing for ease of use
Closed-systems and single-use technologies are becoming a prerequisite for clinical trials and commercial manufacturing of viral vectors. Consequently, we provide PEIpro®-GMP in bags allowing sterile connection compatible with closed-systems to meet customer demands.
Each PEIpro®-GMP bag is fitted with one tubing made of thermoplastic elastomer (TPE) that can either be welded or used with MPC connectors, which ensures compatibility with all stirred-tank and fixed-bed bioreactors (Fig. 2). With PEIpro®-GMP bags, preparation of large-scale complexes is simplified and guaranteed sterile with a simple “plug and transfect” closed system; thereby considerably reducing contamination risks. Should your closed system require a special configuration, please contact us here.
Ease your risk management process
The introduction of any starting or raw material in the manufacturing process of ATMPs adds potential risk factors. It is therefore essential to evaluate each raw material individually through a risk-based approach. By using PEIpro®-GMP as the transfection reagent to produce viral vectors, you can be confident that quality and safety are ensured:
- PEIpro®-GMP is manufactured in accredited GMP facilities in compliance with international GMP guidelines ICH Q7 and correspondingly with EU “Guidelines for good manufacturing practices for medicinal products for human and veterinary use” (ICH Q7 and Eudralex Vol 4, Part II, Annex I: Manufacture of Sterile Medicinal Products). The manufacturing process of PEIpro®-GMP is fully documented.
- PEIpro®-GMP is provided in bags with MPC connectors and weldable tubing suitable for use in closed systems to decrease contamination risks.
- The aseptic filling process is validated through the performance of media fill tests (MFT).
- The quality of PEIpro®-GMP is continuously assessed during the manufacturing process in compliance with GMP control testing guideline. Extensive Quality Controls to assess Identity, Potency, Purity and Safety.
- Identity testing protocols as well as identity satellite sample are available upon request.
- In order to meet any regulatory requirements and to secure your supply chain, we would be happy to establish Quality Agreements with our customers.
Expert Regulatory and Technical support teams
Are you concerned about future changes in regulation? 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 Regulatory Support Team is there to accompany each of you by offering their regulatory expertise.
We offer regulatory support for your IND applications to the US FDA and for submission to any European Regulatory Agency with:
- The 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.
- The documentation describing the Chemistry, Manufacturing and Control (CMC) for IMPD submission or Marketing Authorization to any European Regulatory Agency.
We welcome audit request from customers to qualify Polyplus-transfection® as an approved supplier of raw materials used in the manufacturing of clinical grade therapeutic products. Please contact us here if you would like to perform an audit of our Quality Management System and facility.
“Many of the plasmids made at Aldevron are used for lentivirus or AAV production. We have a lot of experience with different transfection agents. The scientists at Polyplus are world-class and have done a great job in developing enabling technologies like PEIpro-GMP.”
– Michael Chambers, CEO at Aldevron