Specifications

Product information

PEI-based reagent
Synthetic and Free of any animal-origin component

Applications

Viral vector manufacturing using adherent and suspension HEK-293 derivative cells .
Successful biologics produced: rAAV, rLV, adenovirus, retrovirus, Virus-like particles (VLP), influenza virus, antibody, protein.

Number of transfections

1 L of PEIpro® transfection reagent is sufficient to transfect on average 500 L of cell culture (using standard conditions)

Storage condition

Store PEIpro® at 5 °C ± 3°C.
Expiry date is indicated in the certificate of analysis and on the product.

Product documentation

Protocol
Certificate of Analysis
Certificate of origin
Non-hazardous product statement

Regulatory documentation (PEIpro®-GMP only)

Certificate of compliance
Drug master file
CMC section (Chemistry, Manufacturing and Control)
Regulatory support package
Quality agreement
Protocols for identity, concentration, and activity testing

Overview

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. 

Ordering Information

Reference NumberProductAmount of reagent
101000017PEIpro®PEIpro® 1.5 mL Vial
101000033PEIpro®PEIpro® 10 mL Bottle
101000026PEIpro®PEIpro® 100 mL Bottle
101000029PEIpro®PEIpro® 1 L Bottle
101000052PEIpro®-HQPEIpro®-HQ 100 mL Bottle
101000039PEIpro®-HQPEIpro®-HQ 1 L Bottle
102000131PEIpro®-GMPPEIpro®-GMP 10 x 10 mL Bottle (PETG)
102000121PEIpro®-GMPPEIpro®-GMP 100 mL Bottle (PETG)
102000008PEIpro®-GMPPEIpro®-GMP 1 L Bag (closed system)
102000005***NO DISPLAY*** PEIpro®-GMP***NODISPLAY***
115-00151.5 ml***NODISPLAY***
115-01010 ml***NO DISPLAY***
115-100100 ml***NO DISPLAY***
115-01L1 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***
301-100100 ml***NO DISPLAY***
301-01L1 L***NO DISPLAY***

Larger pack sizes available upon request. Please contact us .

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Capabilities

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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Product Documents

You have access to all the documents related to the transfection reagent.

Polyplus Database

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Lexicon

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they used it

Testimonials

G
Genethon
"Genethon proudly uses PEIpro for production of pre-clinical batches of Lentivirus & AAV."
FB
Franziska Bollmann
Process Technology Consultant , Sartorius
“With PEIpro® we were able to consistently obtain high titer lentivirus produced in suspension culture. Unlike with other transfection reagents, we didn't see any toxicity to the cells when using PEIpro®. The protocols and application support provided by Polyplus Transfection helped us to rapidly and efficiently find the optimal conditions for the transfection step.”
MC
Michael Chambers
CEO at Aldevron
"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."
NR
National Research Council Canada
"At the NRC our preferred transfection agent is PEIpro (Polyplus-transfection); because this is GMP ready and in our hands gives highly reproducible titers."
Learn more

Resources

Articles

Optimizing Plasmid Ratios to Enhance rAAV Production
Complete guide on Polyplus GMP
Working Towards an AAV Platform in 2023: Challenges, Threats & Opportunities

Webinars

Webinar Replay : Optimization-by-Design – A critical factor in successful viral vector scale up
Webinar Replay : Straightforward AAV manufacturing process scale up from bench-scale to 2000L STR
Webinar replay: Next Generation of Genetic Engineered AAV Helper Plasmids

Visuals

Poster : Next-Generation Transfection Reagent for Large Scale AAV Manufacturing
Infographic : GMP AAV manufacturing process using FectoVIR-AAV in Allegro 2000 L bioreactorGMP AAV manufacturing process using FectoVIR-AAV in Allegro 2000 L bioreactor
Poster : Addressing Large-Scale Therapeutic Virus Production Using High Quality Grade PEI-based Transfection Reagents

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