Texcell
Major Drugs - Ballenger Creek, MD, US
Texcell Details
Texcell is a dedicated partner for biotechnology and pharmaceutical companies since more than 2 decades. Thanks to an unique combination of expertise in Virology and Immunology, we can provide a full support to your product development from the proof of concept to clinical studies and GMP manufacturing. Our state-of the Art facilities are located in France, Germany and in the US where we use most recent technologies to efficiently perform a wide range of assays What do we provide ? A specialized analytical lab for your preclinical and clinical studies, including: - Cell based assays/potency assays during development - Immunogenicity, TK/PK, ADA and neutralizing Antibody Testing - Immunotoxicology studies - Sample pre analytics: serum/plasma isolation, PBMC isolation & storage - Biobanking - Read-outs: ELISA, ECLIA, Flow cytometry, ELISpot, HAI, proliferation... Texcell Viral Safety lab: Expertise in biosafety of biological and pharmaceutical products. - Virus/TSE Validation - Viral Clearance study - 25 model viruses available - spiking in L2 and L3 labs... - Viral safety testing - a complete range of tests (NGS, in vitro, in vivo, TEM, Q-PCR…) to characterize cell banks and ensure microbiological safety (viruses, mycoplasma, etc…). - Cell and Gene therapy (ATMPs) and Biodistribution/biodissemination - experience with adenovirus, retrovirus, lentivirus... - Virucidal Norm and cleaning validation - Standard Toxicology and Medical Device Biocompatibility studies (ISO 10993) Texcell GMP cell bank facility: Expertise in handling and growing more than one hundred mammalian cell lines. - Production of RCB, MCB and WCB in GMP - Modern class B and class C cell culture room - Dedicated class B room to fill automatically cells in vials - Culture of adherent and suspension cell line with single use disposable - Viral safety control of cell banks performed directly in-house For more information visit www.texcell.com.
Texcell Technologies
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