PEIpro®-GMP

Tech Support Documents
PEIpro®-GMP
 

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 (such as AAV, LV, etc.) for cell and gene therapy. PEIpro®-GMP is available for large scale production.

Amount of Reagent
Item No.: 
102000008
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

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.

Key Benefits:

  • Gold Standard Reagent: Optimized PEI-based transfection reagent for scalable viral vector production (both adherent and suspension systems).
  • Reproducible: Equivalent viral vector production yields guaranteed with 3 quality grades available - PEIpro® , PEIpro® -HQ and PEIpro® -GMP.
  • GMP Grade Availability: Validated Manufacturing process following ICH Q7 guidelines, provided with full regulatory documentation.
  • Residual Test Availability: Our residual method detection to mitigate risks and ensure patient safety.

Applications

  • Application
    • 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.

Biological Information

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

Compliance Information

  • GMP Compliance
    Yes
  • Origin
    Animal-Component Free
  • Product Documentation
    • Protocol 
    • Certificate of Analysis 
    • Certificate of origin 
    • Non-hazardous product statement
    • Drug master file
    • Regulatory support package including toxicity statement
    • Quality agreement 
    • Protocols for identity and activity testing

General Specifications

  • Amount of Reagent
    PEIpro®-GMP 1 L Bag (closed system)

Storage Conditions

  • Storage Conditions
    5 °C ± 3 °C