Texcell
- Founded
- 2003-01-01 in Paris, France
- Headquarters
- Évry, France
Texcell is a specialized global contract research organization (CRO) focused exclusively on viral safety and biosafety testing for biopharmaceuticals, vaccines, medical devices, cell and gene therapies, and other complex biological products. Founded in 1987 as a laboratory within the Pasteur Institute in Paris, Texcell was established to address the critical need for viral safety assessment following HIV contamination events involving blood-derived products. The company became an independent entity in 2003 and has since grown into a recognized leader in viral clearance studies, cell banking, and bioassays. With headquarters in Évry, France, Texcell operates facilities in the United States (Frederick, Maryland), Germany, China, Taiwan, and Japan. The company employs approximately 140 professionals and serves a global clientele spanning R&D, GLP, and GMP programs. Its core services include viral clearance validation, viral safety testing, GMP cell banking, custom cell culture, and in vitro/in vivo bioassays. Texcell’s scientific rigor and regulatory expertise have made it a trusted partner for pharmaceutical developers seeking to ensure the safety of their products before clinical use.
Detailed Review
History & Founding
Texcell traces its roots to 1987 when Professor Florian (“Nardi”) Horaud founded the Texcell laboratory within the Pasteur Institute in Paris, France. The lab was established in response to the HIV crisis and the urgent need for viral safety testing of blood-derived products. Professor Horaud held prominent positions with the World Health Organization and represented European positions at the International Conference on Harmonization. Her team conducted some of the earliest viral validation studies using HIV-1 virus strains. In 2003, Texcell was spun off as an independent company. A key milestone came in 2005 when it opened its current facility in Évry, France. In 2010, Texcell expanded into North America by acquiring Cell Trends, Inc., a custom cell culture company founded in 1991 by Jeff Schubert and Tracy Staley in Maryland. The North American entity was rebranded as Texcell–North America and relocated to Frederick, Maryland in 2012. Subsequent expansion included acquisition of vivo Science’s German facility in 2016, establishment of offices in Japan (2017), China (2020), and Taiwan, and significant capacity additions in 2023 (US viral clearance expansion) and 2024 (China viral clearance laboratory).
Corporate Structure & Ownership
Texcell is privately held. The North American subsidiary operates under Texcell Group, with a separate board and management team. The company has a global footprint with facilities in France, the United States, Germany, China, Taiwan, and Japan.
Operations & Services
Texcell’s comprehensive service portfolio supports biopharmaceutical development from pre‑clinical through commercial manufacturing. Key service lines include viral clearance studies (design and execution of down‑scaled manufacturing process steps to demonstrate removal or inactivation of viruses), viral safety testing (detection and quantification of viral contaminants in biological products, cell banks, and raw materials), GMP cell banking (master and working cell bank preparation, characterization, and storage), custom cell culture (cell line expansion, conditioned medium production, virus production and purification), and bioassays and immunoprofiling (in vitro and in vivo bioassays, immune response evaluation, qPCR‑based detection). The company operates under GLP, GMP, and GCLP quality systems and serves clients across R&D, clinical, and commercial phases.
Recent Developments
In 2023, Texcell North America completed a major expansion, quadrupling its operational space with a new 27,000‑square‑foot viral clearance facility in Frederick, Maryland. That same year, Jeff Schubert retired after 32 years as CEO/founder, succeeded by Alysia Birkholz, PhD, who had served as COO and Deputy CEO. In late 2024, Tara Crnkovich was appointed Chief Executive Officer of Texcell North America. The company continues to invest in global capacity, including a new China viral clearance laboratory opened in 2024.
Key Products
Viral Clearance Studies
Evaluates the ability of a manufacturing process to inactivate or remove viral contaminants from biopharmaceuticals, using scaled-down models of purification and downstream processing.
Viral Safety Testing
Comprehensive testing for adventitious viruses in raw materials, cell banks, and final product, including in vitro and in vivo assays, PCR, and electron microscopy.
Cell Banking (GMP)
GMP-compliant manufacturing, characterization, and testing of master and working cell banks, including identity, purity, stability, and contamination testing.
BioAssays (In Vitro)
Immunoassay-based testing for bioanalysis and immune response evaluation, including potency assays, neutralizing antibody assays, and biomarker quantification.
In Vivo Testing
Animal-based studies for safety and efficacy assessment, including animal virus challenge models and small animal efficacy studies.
Prion Clearance
Validation studies for prion removal or inactivation from biological products, relevant for tissues and blood-derived therapies.
Raw Materials Testing
Viral and mycoplasma testing of raw materials used in biopharmaceutical manufacturing.
Viral Safety & Biosafety Testing
Testing for biological products, cell banks, raw materials, and cell-derived products to detect and quantify viral contaminants.
GMP Cell Banking
Manufacturing, characterization, and testing of cell banks under GMP conditions, including cell line expansion, research cell banking, and conditioned medium production.
Bioassays & Analytical Support
In vitro and in vivo bioassays, immune response evaluation, qPCR-based detection, and related testing for preclinical and clinical programs.
Custom Cell Culture
Custom cell line expansion, virus production and purification, and other cell culture services for R&D and production.
Immunoprofiling
Immunology-dedicated technology platform offering GLP assay development services (optimization and validation) for immune response assessment.
Bioassays & Immunoprofiling
In vitro/in vivo potency assays, immune response profiling, and qPCR‑based detection.
Offices & Headcount
140 employees (approx.)
Key Persons
- Jeff Schubert
Founder & Former Chief Executive Officer – North America
- Tracy Staley
Co-Founder – North America
- Alysia Birkholz, PhD
Former Chief Executive Officer – North America (appointed Oct 2023)
- Eric Henriet
President & CEO (Global)