Qualifying, Standardizing and Automating Immune Assays
ImmunoSite Technologies, LLC (IST) offers a full range of contract research (CRO) immune monitoring services to leading biotechnology, pharmaceutical, and academic organizations around the world. IST services and products span all stages of drug discovery and development – from discovery and preclinical to clinical and market approval. The company has built a worldwide reputation for CRO services related to qualifying, standardizing and automating assays associated with cell-mediated immunity.
Together, the IST team has more than 110 years of IVD product development and ISO9001:13485 manufacturing experience with over 200 successful diagnostic product reagents, kits, and instrument systems, many related to immune monitoring. They also have over 30 US and international patents. The IST management team is 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.
Building upon this solid foundation of immunology 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.
Full Automation Is Key To Standardization
“In order to obtain consistently reproducible results, especially over extended periods of time, we standardize every possible aspect of an assay” explains IST president and CEO, Dr. Wade Bolton. “We look for every opportunity to eliminate or reduce variability. We start with using qualified reagents, controls, and standards. Automation has proven effective in standardizing timing and process steps. Full automation of our phenotypic and functional cell-mediated immune assays has contributed greatly to reproducibility and accuracy. In this way, we are able to provide our partners with documented results and clinical relevance, accelerated discovery and reduced costs.”
Automated assays deliver reproducible results.
Precise and Accurate Results
At IST’s GLP-compliant laboratories, automated immune monitoring 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 and biotech 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.
