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..................Viral Safety & Immunology GLP/GMP Services

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Assay development and validation

Developing and validating appropriate biological assays is one of the key milestones on the road to success for biopharmaceutical products.
Texcell offers the complete development, optimization and validation of tests in a GLP laboratory that includes: definition of appropriate conditions, writing of validation plans, standard operating procedures (SOPs) and validation reports.
For advanced development programmes, we propose a technology transfer of your current protocols under strictly confidential conditions, followed by validation and testing in our GLP-approved laboratory

immuno Test Development
  • Assay development and optimization
  • Feasibility studies
  • Technology transfer of existing assays

Test Validation

  • Parameters for evaluation: accuracy, specificity, sensitivity, working range   (detection limits),    reproducibility, linearity, robustness, stability (freeze-thaw, long-term stability), etc.
  • Validation plan, SOP writing & the Validation Report

Sample Testing

    • Study plan
    • Sample receipt & testing, in accordance with validated SOPs
    • GLP report
 
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