A full range of regulatory tests in compliance with GLP and cGMP, with more than 200 qPCR tests available. Capability to develop and validate innovative, sensitive, specific and robust tests in accordance with ICH Q2 R1.
GMP PRODUCTION and STORAGE
Production of Eucaryotic and Procaryotic cell banks, Viral banks and Storage in liquid nitrogen or -80°C.
Production of cell models which express molecules of interest.
Transfection, cloning, selection, amplification.
Analysis in vitro of the cell responses: measurement of viability, proliferation, phenotype, specific functions (ex. ADCC, apoptosis, CDC), interferon activity.
Development and validation of qPCR tests: detection quantification of pathogens or contaminants, residual DNA, determination of sites of insertion of a transgene, gene copy number.
Development and validation of virus titration method.
Detection and validation of recombinant competent replication tests (rcAAV,RCL) for gene therapy.
ADVANCED MEDECINE THERAPY MANUFACTURING FOR PHASE I/II
GMP manufacturing platform for bacteriophages and cell therapy products for phase I / II clinical trials.