Texcell / BioAssays in vivo / Potency Assay Potency Assay “Determining the biological activity of cell based immunotherapy products is not easy since the active ingredient is usually composed of whole cells and the activity of these products can generally not be attributed to one specific cell characteristic. The potency (i.e., the quantitative measure of biological activity) of cell based products can be measured using in vivo or in vitro tests. An appropriately validated potency assay should be based on a defined biological effect as close as possible to the mechanism(s) of action/clinical response.” (EMA/CHMP/BWP/271475/2006 rev.1) Texcell is developing or transferring custom bioassays with several readout possibilities: In vivo on small animals In vitro in cell lines or primary cells Results are computed according to the parallel line method (US/European Pharmacopoeia). Bioassays are used for various purposes, such as: Proof of concept Neutralizing potential of unwanted antibodies against biologicals (ADA); Potency assays for batch release and stability testing Contact us now and get started! Biosafety Viral Clearance GMP Cell Banking Research Cell Banking Medical Devices BioAssays in vitro BioAssays in vivo Cell Proliferation Biodistribution Immunogenicity Potency Assay Pharmacokinetic Tumorigenicity Toxicology Works contracted to Texcell SA might be eligible to Research Tax Credit (Crédit Impôt Recherche). Please inquire. Texcell SA 1, rue Pierre Fontaine 91058 Evry Cedex FRANCE Texcell Asia Level 37, Tapei 101 Tower n°7 Section 5 Xinyi Rd101 Taipei, TAIWAN Vivo Science FabrikStr. 3 48599 Gronau GERMANY Texcell Japan 4F Pacific Marks Nishi-Umeda 2-6-20 Umeda, Kita-ku, Osaka 530-0001, JAPAN Texcell North America 4991 New Design Road Frederick MD 21703 USA +1 (301) 363-5600 Follow us on LinkedIn ! Mentions légales - © 2020 Texcell We'll assume you're ok with this, but you can opt-out if you wish.AcceptReject