Our fully integrated protein manufacturing services covers all needs from initial process development to manufacturing at research, HQ and GMP grade.
Meet our team booth #A3 during the Cell Therapy Manufacturing Congress in Kyoto (Japan), February 27th – March 2nd, 2018.
Optimized PEI-mediated production of clinical grade viral vectors, PEIpro® and PEIpro®-HQ
Gene- and cell therapy-based medicines are experiencing resurgence due to the advances made in developing new viral vector systems guided by safety, specificity and potency considerations. Adeno Associated Virus (AAV) and Lentivirus are very commonly used in therapeutics and often produced using PEI-mediated transient transfection in HEK-293 or HEK-293T cells. The critical raw materials needed for cGMP vector production must be sourced from approved suppliers and should have gone through a rigorous testing program to reduce the risk of introducing adventitious agents into the production process. PEIpro® and PEIpro®-HQ, provided and manufactured by Polyplus-transfection®, are the unique PEIs developed for transfection and suitable for virus production from process development up to use in GMP processes, respectively.
Part: Production Considerations – Facilities linked to manufacturing strategies
Thursday, 1 March 2018 15:10 – 15:40
Our solutions for Cell Manufacturing
in vivo delivery of nucleic acids represents a novel promising approach for some medical applications such as gene and oligonucleotides therapy. Polyplus-transfection® offers a cGMP grade in vivo-jetPEI® which is manufactured in compliance with applicable European Commission (EC) guide to Good Manufacturing Practices (GMP) and FDA requirements for clinical trials phase I to III. This reagent is used worldwide for a growing number of therapies based on nucleic acid delivery.
PEIpro®-HQ is a highly qualified grade of PEIpro® reagent, especially developed for the production of clinical batches of recombinant proteins, antibodies or viral vectors. The PEIpro®-HQ grade is supplied with appropriate Quality Controls and documentation allowing its use as a qualified raw material in GMP processes for the manufacturing of clinical batches of therapeutic products.
FectoPRO® Transfection kit is specifically designed for enhanced Transient Gene Expression (TGE) in suspension CHO and HEK-293 cells in various serum-free media, using low DNA amount (< 1 µg/ml of cell culture).
PEIpro® is a DNA transfection reagent for production of viruses, recombinant proteins and antibodies either in adherent cells in presence of serum or in suspension HEK-293 cells grown in low serum or serum-free media.
The convention will take place at The Westin Miyako (Higashiyama-ku, Tanigawachō, Keage, Sanjo, Higashiyama Ward, Kyoto 605-0052, Japan):
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