CONTRACT LABORATORY SERVICES (CRO)

Cell Mediated Immune Monitoring (CMI) in Our Contract Laboratory

Our contract laboratory offers:

Whole Blood Processing to Cryopreserved PBMC

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T Cell ELISPOT Testing

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B Cell ELISPOT Testing

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ELISA Testing

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Flow Cytometry Testing

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Sample Management

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Assay Standardization

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Scanning & Analysis

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Neutralizing Antibody (NAb) Assays

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We are specialized in immune monitoring of CMI with emphasis on T and B cell (e.g. antigen specific plasma B cell and antibody producing memory B) evaluations within pre-clinical and clinical studies. Thanks to our in-house expertise and rigorous procedures, we can conduct all assays including ELISPOT, ELISA, NAb, NK- killer assay, CBA, FACS, proliferation, and more...in our regulated laboratory—whether to establish, to perform qualification-validation, test samples to satisfy FDA requirements or simply evaluate specimens for scientific significance.

We provide comprehensive solutions for PBMC sample processing: Serving as central whole blood processing laboratory with optimized logistic, separation of PBMC, cryopreservation to ensure exceptional cell functionality of cryopreserved PBMC in the antigen specific ELISPOT assay and storage.

Our GCP, GLP regulated laboratory is as well CLIA/CLEP certified/approved, Part 11 compliant, specializes in custom client Laboratory Developed Tests (LDT) in accordance with FDA guidance for Bioanalytical Method Validation; and capable of processing up to 450 samples per week.

 

CTL's Certificates and Licenses:

   California Clinical Laboratory License ID: COS 00800918

   Maryland Department of Health, Office of Health Care Quality Medical Laboratory Permit

   New York State Department of Health Clinical Laboratory Permit

   State of Rhode Island and Providence Plantations Department of Health Clinical Laboratory Permit

   State of Pennsylvania Department of Health Clinical Laboratory Permit

 

We also provide high-throughput data acquisition, evaluation, and quality control, allowing us to process large assays within a relatively short amount of time. For new clients, we can schedule an initial telephone conference to discuss how our products and services can assist you in achieving your goals.

CTL has been providing contract laboratory services for government laboratories, major pharmaceutical companies, biotechnology companies, and academic institutions for over 15 years. Our company has been recognized by the Cancer Vaccine Consortium as its ELISPOT reference laboratory and has been awarded a contract by the U.S. National Institutes of Health (NIH) to validate the ELISPOT assay for pre-clinical and clinical trials. CTL is a member of the Society of Quality Assurance (SQA) and the Regulatory Affairs Professionals Society (RAPS). Our lab has been certified for Cell Viability by the International Society for Biological and Environmental Repositories (ISBER).


For further information or a quote, please contact us today.

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Cellular Technology Limited (CTL)
20521 Chagrin Boulevard | Shaker Heights, Cleveland, OH 44122-5350 USA
+1 216-791-5084 | +1 216-751-1373 Fax | +1 888-791-4005 Toll Free US
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