Biological assay development and validation

Biological assays are experimental methods for assessing the presence, localization, or biological activity of a substance in living cells and biological matrices. Such methods are essential to biological science and technology. Many applications require novel assays to answer new questions, and existing assays must be implemented in a way that is robust and reproducible. Assay development and validation are routinely performed at SRI. Our scientists develop biological assays for application to basic science, drug discovery and development, and creation of diagnostics.

Measurements made on cultured cells provide information about the chemical and physical state of the cells. These assays probe the biological effects of changing physiological conditions or added agents such as drugs or toxins. SRI researchers use cell-based assays to identify new therapeutic targets, discover new drugs, test chemicals for toxicity, detect pathogen infection, engineer cell function, and study the normal mechanisms underlying cell behavior.

Functional genomics is a field of biology that focuses on the expression and function of genes and their protein products. It comprises methods to study and characterize the molecular interactions that translate into structure, function, and behavior of cells and organisms. Tools to measure many products of gene expression in parallel are essential to this area of research. They include proteomics methods for characterizing complex collections of proteins.

Imaging technologies enable scientists to see biological phenomena that are invisible to the unaided human eye. Biologists at SRI apply imaging and image analysis methods to a wide range of investigations, including detecting and locating proteins within living cells and tissues, visualizing the internal structures and biochemistry of living organisms, and visualizing biological structures that are simply too small to see.

SRI’s Clinical Analysis Laboratory is fully compliant with FDA Good Laboratory Practice (GLP) regulations and uses state-of-the-art instrumentation and data management to offer full capabilities for standard and specialized services for both human and veterinary clinical research samples.

SRI is a leader in the development and application of in vitro models for ADMET evaluations (ADMET: Absorption, Distribution, Metabolism, Excretion, and Toxicity). Obtaining data on potential toxicity early in the development process can help you make informed decisions to move promising leads forward and exclude liabilities. Our staff has extensive experience in elucidating tissue-specific mechanisms of toxicity for various species and organs. We pioneered the application of human tissue preparations to predicting interspecies differences in drug metabolism, potential drug interactions, and human drug metabolizing enzymes.

SRI offers comprehensive drug metabolism and pharmacokinetic (DMPK) services to meet your needs. We give you access to a complete range of capabilities, beginning with dose administration followed by full-service bioanalytical support and pharmacokinetic data analysis and interpretation. We offer PK studies that fully comply with U.S. FDA GLP regulations.

SRI International Immunology Services Facility provides quality services in the area of immunology, virology, autoimmunity and inflammation that covers all stages of drug discovery and development. With state-of-the-art instruments, laboratory, and validated software systems, the Immunology team offers customized services to meet clients’ needs which includes but is not limited to assay development and validation for preclinical and clinical studies, as well as preclinical and clinical sample analysis.