Contract Laboratory Services

Contract Services for Immune Monitoring

Our CLIA-certified CRO provides expert immune monitoring services for major pharmaceutical companies, biotechnology companies, government laboratories, and academic institutions. For more than 20 years, we have been providing comprehensive solutions for accurate, reliable immune assays and whole blood/PBMC processing.

Blood processing and PBMC cryopreservation

There are many challenges to monitoring T or B cell-mediated immunity, beginning with the shipping and cryopreservation of live blood cells. Our highly trained CRO team specializes in the logistics, separation, and cryopreservation of functional PBMC in a regulated environment to support your preclinical or clinical studies.

Thanks to our in-house expertise and rigorous procedures, we can serve as a central whole blood processing laboratory for multi-site clinical studies. Our optimized processes ensure exceptional cell functionality of cryopreserved PBMC for use in antigen-specific ELISPOT assays and storage.

Our high-quality, regulated environment

Our company was founded by pioneers in immune monitoring of cell-mediated immunity (CMI), with emphasis on T and B cell assays. This deep expertise is evident in all areas of the company, in particular the CRO.

Our highly trained team expertly performs a variety of assays in our regulated laboratory—whether to establish, perform qualification-validation, test samples to satisfy FDA requirements, or simply evaluate specimens for scientific significance.

Assays we perform include:

ELISPOT
ELISA
Neutralizing antibody
Natural killer
Cytometric bead array
Fluorescence-activated cell sorting
Proliferation
And more

Our GCP- and GLP-regulated laboratory is CLIA/CLEP certified/approved, Part 11 compliant, and specializes in custom client laboratory developed tests (LDT) in accordance with FDA guidance for bioanalytical method validation. Our high-throughput capabilities allow us to process up to 450 samples per week.

California Clinical Laboratory License ID: COS 00800918

• Clinical Laboratory Improvement Amendments (CLIA) certificate ID : 36D1100176
• 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 License Number: LCO01323
• State of Pennsylvania Department of Health Clinical Laboratory Permit

Our team also provides high-throughput data acquisition, evaluation, and quality control, allowing us to process large assays within a relatively short amount of time.

For our potential new clients, we will schedule an initial telephone conference to discuss how our products and services can assist you in achieving your specific goals.