Bioanalytical Services Information
Bioanalytical services perform pharmaceutical, agricultural, biological, microbial and other life science testing and analysis activities. Bioanalytical services are a subset of companies within the larger field of biotechnology, the science of using biological systems or living organisms to make useful products. For example, a bioanalytical service in the pharmaceutical industry analyzes chemicals or micro-organisms to learn more about their properties and develop new drugs. Bioanalytical services are used throughout the entire drug development lifecycle. They perform pharmacokinetic and pharmacodynamic screening and provide expertise with mammalian cell-based assays, biomarkers, radiochemistry, immunoassays, and electrophoresis.
Bioanalytical services use bioassays to measure the effects of a substance on a living organism. A bioassay can be used to determine the toxicity of a specific chemical contaminant, or to determine the concentration of a substance in bone or tissue. Bioaccumulation refers to the buildup of substances such as pollutants or pesticides in an organism. During the drug approval process, pharmaceutical companies may hire bioanalytical services to ensure that newly developed products do not bioaccumulate to toxic levels in test samples.
Some bioanalytical services specialize in microbiology, a branch of biotechnology devoted to the studies of organisms such as bacteria, yeasts, algae and protozoa that could be either helpful or harmful to humans and the environment. The scope of microbiological studies includes microbial physiology, the study of microbial cell functioning microbial genetics, the study of how genes are organized in relation to their cellular functions; medical microbiology, the study of how microbes relate to human illnesses; veterinary microbiology, the study of how microbes relate to animal illnesses; environmental microbiology, the study of microbes in their natural environment; and industrial microbiology, the study of using microbes in industrial processes. Bacteriological applications for microbiology include medicine and agriculture.
In the United States, bioanalytical services that serve the food or pharmaceutical industries must meet requirements established by the Food and Drug Administration (FDA). In Europe, companies must comply with relevant health and safety directives from the European Union (EU).