A four to five-week turnaround time for up to 1,000 subjects assayed for antigen-specific cytokine responses allows you to significantly accelerate immune monitoring of patient samples.
CTL has many years of experience in performing contracted laboratory services. Its laboratory complies with Clinical Laboratory Improvement Amendments (CLIA) and US Food and Drug Administration (FDA) regulations, including 21 CFR Part 58 and 21 CFR Part 11.
CTL’s greatest strength lies in its high-throughput T-cell monitoring capabilities and world-class Enzyme-Linked ImmunoSpot® Assay (ELISPOT) expertise. The company offers a four to five-week turnaround time period for processing, testing, and data analysis of up to 1,000 specimens.
In addition, CTL’s good laboratory practice (GLP) laboratory’s high-throughput capability allows you to significantly accelerate the development process for drugs and vaccines entering the clinical testing phase, as well as subsequent immune-monitoring of patient samples.
Due to CTL’s in-house expertise, the company can conduct all cell-based immune monitoring assays (with an emphasis on T cells) in a GLP-compliant manner. It can develop and validate test methods to suit your needs and accommodate FDA requirements.
CTL specialises in high-throughput immune monitoring, ranging from specimen processing to data acquisition, analysis and quality control.
ELISPOT assays and the related multiplex FluoroSpot technology are ideal for measurements of specific per-cell cytokine production and direct ex-vivo cytotoxicity assays. Testing of T-cells for simultaneous secretion of multiple cytokines indicating the presence of polyfunctional T-cells, T-cell functional avidity studies and epitope mapping, and B-cell ELISPOT assays for determining the class or subclass of antibody-secreting cells, are just a few areas where ELISPOT and FluoroSpot are used.
CTL Laboratories has on-site facilities for processing whole blood, peripheral blood mononuclear cell (PBMC) isolation, and cryopreservation of lymphocytes for later functional assay testing, allowing the company to act as a central processing facility for multisite studies. It is fully equipped to handle the logistics of collection, processing, cataloguing, and cryo-storage of samples from multiple clinical collection sites.