BioAssays in vitro
Texcell provides a large array of bioassays to accompany you in your drug development or your production lot in compliance with GLP/GMP regulations.
We can test small molecules and biotechnology-derived drugs, chemicals, stem cell therapies, advanced therapy medical products, implantable devices and endocrine disruptors.
Our team of scientists can develop fully customized bioassays in our ELISA, ECLIA, ELISPOT and flow cytometry platforms in R&D mode. If required, they can also validate and transfer the assay in accordance with FDA, EMA and ICH guidelines. Use our tests to perform batch release and characterized efficacy of your production lot.
Neutralization
Texcell’s immunoassay Laboratory expertise provides you wide panel of in vitro tests for bioanalysis and evaluation of the immune response for biologicals. Texcell offer investigative in vitro tests for a large number of drug products, including blood derived products, antibodies, cell and gene therapies, nanoparticles. Our proven in vitro tests offer insights on the activity of your test item from early proof of concept to clinical phase 4. Thank to our cell culture capabilities, we can also provide cell-based assays.
Potency Assay
Our scientific team develops and validates custom in vitro tests in accordance with regulatory guidelines. Full validation includes precision, accuracy, recovery, linearity and stability in accordance with bioanalytical validation guideline ICH Q2R1 as well as FDA and EMA guideline. In vitro tests can be transferred to or from your organization.
Following PBMC isolation, we can also perform in vitro test on clinical samples from Phase 1 to Phase 4.
Biomarkers Expression
Texcell offers the complete development, transfer and optimization of in vitro bioassays. For advanced development programs, we propose a technology transfer of your current protocols under strictly confidential conditions, followed by validation and testing in our GLP/GcLP/GMP-approved laboratory.
- Proof Of Concept
- Feasibility studies
- Test Development
- Validation
- Testing
Cytokines Expression
As key mediators of the immune and inflammatory systems, cytokines are used as markers to assess how drug candidate modulates functions including innate and adaptive immunity, inflammation, immune cell differentiation, angiogenesis, tumorigenesis, development, neurobiology, and viral pathogenesis. Texcell dedicated immunology platform offers proven, state of the art technologies for singleplex and multiplex assays to support your cytokine and chemokine research needs.
GLP, GcLP, GMP custom study
Results of your validated in vitro test are audited by our internal quality department in order to provide Certificate of Analysis.