History of IST

Over a Decade of Specialization in Diagnostic Cellular Analysis and Immune Monitoring

ImmunoSite Technologies, LLC (IST) was formed in 2009 with the genesis of the company some ten years earlier when Beckman Coulter Corporation (BEC) formed the  innovative Custom Biopharma Solutions (CBS) department to address specific needs of the pharmaceutical industry, particularly in preclinical and clinical trials.   CBS brought together a specially selected group of scientists, physicians, engineers, clinical laboratory technicians and quality professionals.  The goal was to implement comprehensive solutions in immune monitoring and surveillance, flow cytometry, application development, automation, particle characterization, assay development and testing for the clinical research, pharmaceutical, and biotechnology industries.

Over their 10+ years together providing custom biopharma solutions to clients, this dynamic and highly productive team founded ImmunoSite Technologies and brought their 110 years of rigorous product development experience, over 300 peer-reviewed scientific publications, inventorship on 30 U.S. and international patents, and success in developing over 200 diagnostic (IVD) product reagents, kits and instrument systems.

Work With World-Class Organizations

The IST management team has been, and continue to be, distinguished by their work with world opinion leaders in immunology, oncology, diagnostics and therapeutics, and are often asked to present at national and international congresses.  CBS, and now IST, was chosen by world-class clinical trial and research organizations to identify and establish controls and calibrators for immune system assays, and to standardize, automate and conduct testing of patient samples from ongoing clinical trials.   The Immune Tolerance Network selected the IST team to establish both its assay development research and clinical testing laboratories for its large network of NIH-funded clinical trials in allergy, asthma, diabetes, multiple sclerosis, transplantation, and autoimmunity.  The ITN stated that the primary reason for choosing the IST team was their years of clinical assay development experience and their ability to make assays standardized and reproducible to the high levels of quality required by the FDA.  This reproducibility meant that, from site to site and continent to continent, the assays would be performed in the same manner and the results would be comparable across the board.

Another leading clinical trial organization, the Immune Tolerance Institute, choose the IST team to assist them in the immunophenotypic testing of their clinical samples, including the more complex T-reg assays requiring high-speed sorting and in vitro cell culture assays.

The Imperial College London managed CD4 Initiative, funded by the Bill and Melinda Gates Foundation, chose IST to develop CD4 control cells to be used in a novel, disposable, CD4 enumeration point-of-care test designed for use in underdeveloped countries (see press release for more information). The CD4 Sure Control Cells™ are a preparation of lyophilized, peripheral blood, mononuclear cells that have been isolated from normal peripheral blood and contain a known number of CD4 T and CD45 positive mononuclear cells.  These reagents are used as a quality control (QC)/external quality assurance (EQA) for CD4 point-of-care testing sites.

History & Experience Lead To Unique Capabilities

Using the years of experience in product development and clinical trial patient testing, IST offers a suite of unique, proven, functional, immune monitoring assays as a testing service for pharma and biotech companies, as well as trial organizations, involved in immune-based drug and biologics discovery and development.  These assays are fully standardized and automated, and have undergone rigorous validation and verification, with data to support the accuracy, precision, inter- and intra-assay verification, specificity, and limit of detection.  At IST’s GLP-compliant laboratories, these automated assays are performed within tight specifications yielding precise and accurate findings with a fast turnaround time.  This helps IST to ensure that the data collected on clinical trial patient samples are of the highest quality to support pharma investigations.  Additionally, these types of assays have successfully been used to follow drug candidates through all phases of clinical trials over periods as long as 18 to 24 months, and may emerge as a companion diagnostic for therapeutic stratification or monitoring.

Bill & Melinda Gates FoundationImperial College LondonThe CD4 Initiative