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Viral vector manufacturing using adherent and suspension HEK-293 derivative cells .
|Number of transfections|
1 L of PEIpro® transfection reagent is sufficient to transfect on average 500 L of cell culture (using standard conditions)
Store PEIpro® at 5 °C ± 3°C.
|Regulatory documentation (PEIpro®-GMP only)|
Certificate of compliance
PEIpro® transfection reagent is the leading PEI-based DNA transfection reagent that offers flexibility and scalability to develop a robust and sustainable viral vector manufacturing process. PEIpro® benefits from extensive research development in PEI polymer chemistry and formulation to achieve highest transfection efficiency in both adherent and suspension cell culture systems. PEIpro® allows a smooth transition from initial process development to large scale manufacturing of therapeutic viral vectors with three quality grades available: PEIpro®, PEIpro®-HQ and PEIpro®-GMP. PEIpro®-GMP is the highest quality grade PEI-based reagent on the market and is provided with a full regulatory documentation to support drug approvals.
|Reference Number||Product||Amount of reagent|
|101000017||PEIpro®||PEIpro® 1.5 mL Vial|
|101000033||PEIpro®||PEIpro® 10 mL Bottle|
|101000026||PEIpro®||PEIpro® 100 mL Bottle|
|101000029||PEIpro®||PEIpro® 1 L Bottle|
|101000052||PEIpro®-HQ||PEIpro®-HQ 100 mL Bottle|
|101000039||PEIpro®-HQ||PEIpro®-HQ 1 L Bottle|
|102000131||PEIpro®-GMP||PEIpro®-GMP 10 x 10 mL Bottle (PETG)|
|102000121||PEIpro®-GMP||PEIpro®-GMP 100 mL Bottle (PETG)|
|102000008||PEIpro®-GMP||PEIpro®-GMP 1 L Bag (closed system)|
|102000005||***NO DISPLAY*** PEIpro®-GMP||***NODISPLAY***|
|115-010||10 ml||***NO DISPLAY***|
|115-100||100 ml||***NO DISPLAY***|
|115-01L||1 L||***NO DISPLAY***|
|125-01L||***NO DISPLAY*** 1 L bag||***NO DISPLAY***|
|127-300||***NO DISPLAY*** 300 mL bag||***NO DISPLAY***|
|126-100||***NO DISPLAY*** 100 mL bottle||***NO DISPLAY***|
|126-10x10||***NO DISPLAY*** 10 x 10 mL bottles||***NO DISPLAY***|
|102000001||***NO DISPLAY*** PEIpro®-GMP 1 L Bag||***NO DISPLAY***|
|102000002||***NO DISPLAY*** PEIpro®-GMP 100 mL Bottle||***NO DISPLAY***|
|301-100||100 ml||***NO DISPLAY***|
|301-01L||1 L||***NO DISPLAY***|
PEIpro® offers a seamless transition from process development to commercialization
The extensive research development invested in PEIpro® and the Polyplus® expertise on the manufacturing process has made it a unique PEI-based transfection reagent. As result, PEIpro® has become the gold reference among commercially available PEIs for cell and gene therapy. Three quality grades are available to guarantee the level of process qualification, quality controls, traceability and documentation adapted to each project stage. Both PEIpro® and PEIpro®-HQ are produced in an ISO:9001 environment guaranteeing a high-quality product, whereas the PEIpro®-GMP is produced in GMP certified facilities following ICH Q7 guidelines that ensure a validated aseptic manufacturing process.
A scalable and reproducible transfection reagent ensuring a robust manufacturing process
To ensure robust manufacturing , scale-up or scale-out therapeutic virus production with PEIpro® -HQ or PEIpro®-GMP are guaranteed to be comparable to production yields achieved at small scale with R&D grade PEIpro® during process development. PEIpro® is manufactured and formulated using a highly controlled and strict manufacturing process. By ensuring reproducibility from one run to the next. PEIpro® greatly facilitates process standardization: a key advantage for large-scale production. Moreover, PEIpro® is released using advanced quality controls including a specification for transfection efficiency that guarantees excellent lot-to-lot consistency.
Mitigate your risk management process using PEIpro®-GMP
The introduction of any starting or raw/ancillary material in the manufacturing process of ATMPs adds potential risk factors. 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 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 and Annex I: Manufacture of Sterile Medicinal Products). PEIpro®-GMP is provided in bags with MPC connectors and weldable tubing suitable for use in closed systems to decrease contamination risks. A residual test, to analyze the transfection reagent present/absence in the drug product, is available through selected service providers.
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PEIpro® is the leading PEI-based DNA transfection reagent that offers flexibility and scalability for viral vector manufacturing.
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