Sartorius, 102000008, 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.

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.

Specifications
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