Texcell / Viral Clearance Viral Clearance Why Texcell? Viral Clearance studies are critical in ensuring biological product safety. Texcell offers diverse options for quality data for regulatory submissions. Investigational Viral Clearance Studies We define investigational Viral Clearance studies as For Information Only or “FIO”, and tailor them to be quick, cost conscious, and give the most critical information needed to design a robust GLP Viral Clearance. Consultation Services Texcell’s study directors and scientists have years of experience in purification process development, viral clearance studies, and have played a role in countless FDA, EMA, and other regulatory strategies and submissions for clinical and commercial applications. Texcell can provide guidance/ideas for: Maximizing effective Viral Clearance from your manufacturing platform Performing risk assessments for Viral Clearance performance in advance of parameter setting for process validation Collaborating on experiment planning to get the most from FIO studies Designing Viral Clearance studies for early and late phase regulatory submissions Preparing virus safety assessments for your regulatory submission documents Being an extension of your process development team in meetings with your CMC project team or your CMC regulatory team Designing Viral Clearance experiments for novel manufacturing processes GLP/GMP-compliant Viral Clearance Services Texcell provides GLP/GMP-compliant Viral Clearance services in accordance with EMA and FDA regulations. Good Laboratory Practice (GLP) regulations (FDA 21 CFR Part 58) specifically address the requirements for Viral Clearance testing, whereas Good Manufacturing Practice (GMP) regulations (FDA 21 CFR Parts 210 and 211) are specific to manufacturing. In response to industry trends and periodic Sponsor requests, Texcell has elected to incorporate certain quality elements mandated by GMP regulations into the context of Viral Clearance. Since 1987, Texcell organizations located in the USA, Europe, and Asia have executed a combined total of >10,000 Viral Clearance studies. Texcell’s experienced scientific staff can offer support, guidance, and consultation services for Viral Clearance study design, selection of virus panel, and regulatory compliance. The Viral Clearance products experience includes, but is not limited too; monoclonal antibodies recombinant proteins gene therapy products ortho biologics tissues, bone, and collagen blood products nanoparticles vaccines Biosafety Viral Clearance Virus Panel Study Tiers to Consider Levels of Service Prion Clearance Studies GMP Cell Banking Research Cell Banking Medical Devices BioAssays in vitro BioAssays in vivo 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