PEIpro Transfection Reagent for Cell and Gene Therapy
PEIpro Transfection Reagent for Cell and Gene Therapy 2024 – PEIpro® transcends the ordinary, offering an optimized PEI-based transfection reagent designed for scalable viral vector production in both adherent and suspension systems.
This cutting-edge reagent is not just a facilitator; it is a catalyst for efficiency, reproducibility, and GMP-grade excellence.
Reproducible Excellence: Three Tiers of Quality
One of the hallmarks of PEIpro Transfection Reagent is its commitment to reproducibility. With three quality grades available—PEIpro®, PEIpro®-HQ, and PEIpro®-GMP—equivalent viral vector production yields are guaranteed.
This ensures that the manufacturing process is not just efficient but consistent, laying the foundation for robust and reliable outcomes.
GMP-Grade Availability: Elevating Quality Standards: PEIpro Transfection Reagent
PEIpro® takes pride in its GMP-grade availability, adhering to the stringent guidelines outlined in ICH Q7.
This validated manufacturing process is accompanied by full regulatory documentation, underscoring its commitment to the highest quality standards for active pharmaceutical ingredients (API).
Patient safety is paramount, and PEIpro® ensures that every step aligns with the rigorous requirements of GMP.
Risk Mitigation: A Holistic Approach: PEIpro Transfection Reagent for Cell and Gene Therapy 2024
In the ever-evolving landscape of biopharmaceuticals, risk mitigation is a critical consideration. PEIpro® addresses this concern head-on with its proprietary residual test method, developed by Polyplus.
This method not only detects any remnants of the transfection reagent but also serves as a robust tool to ensure patient safety—a non-negotiable aspect of any therapeutic development.
Applications: A Multifaceted Solution:
The versatility of PEIpro® extends beyond its gold standard status. It finds application in viral vector manufacturing using both adherent and suspension HEK-293 derivative cells.
The success stories of biologics produced with PEIpro® include rAAV, rLV, adenovirus, retrovirus, Virus-like particles (VLP), influenza virus, antibodies, and proteins—a testament to its adaptability and efficacy.
Scalability and Reproducibility: Engineering a Robust Future:
PEIpro® isn’t just about the present; it’s a catalyst for the future. Its scalability and reproducibility make it an ideal choice for the seamless transition from process development to commercialization.
Whether scaling up or scaling out, PEIpro® ensures that therapeutic virus production remains comparable to smaller-scale processes, guaranteeing efficiency at every stage.
Features of PEIpro Transfection Reagent
The gold standard reagent offered by Polyplus is an optimized polyethyleneimine (PEI)-based transfection reagent specifically designed for scalable viral vector production in both adherent and suspension systems. This reagent ensures reproducible results and guarantees equivalent viral vector production yields across three distinct quality grades: PEIpro®, PEIpro®-HQ, and PEIpro®-GMP.
One of the notable aspects of this reagent is its adherence to Good Manufacturing Practice (GMP) guidelines. The manufacturing process is meticulously validated in accordance with International Council for Harmonisation (ICH) Q7 guidelines. Polyplus provides comprehensive regulatory documentation, assuring users of its adherence to stringent quality and safety standards.
Moreover, the reagent offers residual test availability, addressing potential risks associated with residual components. Polyplus has developed its own method for residual detection, enhancing safety measures and ensuring patient safety throughout the vector production process.
In summary, Polyplus’s gold standard reagent stands out for its reproducibility, varied quality grades tailored to specific requirements (PEIpro®, PEIpro®-HQ, and PEIpro®-GMP), compliance with GMP guidelines, validated manufacturing processes, and its proprietary residual detection method, collectively ensuring reliable and safe viral vector production for various applications.
