SubscribeBattelle's state-of-the-art laboratories and test facilities are among the worlds finest in providing the science and technology to combat the threat of chemical and biological weapons. One of Battelle's premier laboratories is the Medical Research and Evaluation Facility, a proven leader in medical chemical and biological defense research, program and project management and technology transition.
Facility Highlights
Battelle’s 83,000 sq. ft. Medical Research and Evaluation Facility (MREF) in West Jefferson, Ohio, is composed of two facilities specializing in the research, development, testing, and evaluation (RDT&E) of medical countermeasures against pathogenic organisms, biological toxins, and highly toxic chemicals to support medical product efficacy testing for Food and Drug Administration (FDA) licensing.
The Biological Defense Research Laboratory is one of few U.S. laboratories capable of studying aerosolized biological agents in living systems under BSL-3 containment and has been in operation since 1995. Since its inception in 1983, the Chemical Defense Research Laboratory has remained one of few biomedical U.S. laboratories capable of safely using highly toxic chemical agents in living systems. In addition to these laboratories, a 30 x 96 ft. steel barn is available with two adjoining pasture areas for housing larger research animals using standard agricultural practices.
Skilled, Knowledgeable, Experienced Research Staff and World Class Capabilities
The MREF maintains state-of-the-art equipment and the professional and technical staffing expertise to safely conductin vitro, in vivo, and analytical chemistry testing and evaluation of biological materials and highly toxic chemicals under the FDA’s GLP (21 CFR Part 58) and cGMP Guidelines.
The MREF specializes in medical chemical and biological defense research.
The MREF is composed of more than 120 scientific, administrative, and support personnel. The scientific and technical staffs are trained in the safe handling of pathogenic, hazardous, toxic, and infectious materials. This staff includes scientists with specialty expertise in microbiology, virology, immunology, immunotoxicology, pharmacology, veterinary medicine, pathology, general chemistry, analytical chemistry, molecular biology, inhalation toxicology, and aerobiology.
In addition, we have technical specialists in facility management, resource management, industrial hygiene, biostatistical analysis, and program and information management. The MREF can link any or all of these specialty areas within a single study.
The capabilities of the MREF molecular toxicology and molecular biology laboratories include real-time quantitative RT PCR, Taqman®, immunohistochemistry, cDNA gene expression array technologies, Northern blot hybridization, ribonuclease protection assays, in situ hybridization, DNA sequencing, cloning and expression, electrophoretic mobility shift assays, flow cytometry, ELISA, Western blot analyses, protein purification, enzyme analyses, bacterial and tissue cell culture, and antibody production. Additionally, the laboratory has the capability to examine peripheral blood leukocytes and to identify and characterize various cellular biomarkers, including cytokines and chemokines. The MREF’s chemistry staff has the experience and resources for handling a wide range of materials, including highly hazardous and unknown materials.
Our chemistry capabilities include United States Pharmacopeia (USP)/FDA methods development and validation, dose identity, materials characterization and concentration confirmation assays, gas chromatography with both capillary and packed columns, high-performance liquid chromatography with multiple types of columns and detectors, mass spectrometry with LC/MS/MS, electrospray, atmospheric pressure chemical ionization, nanospray, GC/MS/MS with electron impact or chemical ionization with solids probes, Fourier transform infrared spectroscopy, and all general and clinical chemistry capabilities.
Rigorous Quality Control
The MREF facilities are ISO 9001 certified, accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), and approved/compliant/inspected by the Centers for Disease Control (CDC) Select Agent Program, the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), Ohio EPA, U.S. Army Inspector General, U.S. Army Medical Research Institute of Chemical Defense Safety and Chemical Operations Branch (SCOB), U.S. Army Medical Research and Materiel Command Office of Animal Care and Use Review, Madison County Health Department, and Battelle’s Institutional Animal Care and Use Committee (IACUC). The MREF is compliant with all applicable U.S. Department of Defense, Federal Government, and State of Ohio regulations to conduct and support activities with biological and chemical agents.
All research activities conducted at Battelle’s MREF are reviewed by an independent Quality Assurance (QA) unit, with experience and knowledge of the requirements of multiple regulatory agencies. The MREF’s QA Program and staff ensure that personnel, facilities, equipment, methods, practices, records, and controls conform to all applicable regulatory requirements.
QA staff audit critical events, monitor compliance with Standing Operating Procedures dealing with test systems handling and care, conduct laboratory tests, perform data andling/storage/retrieval, and prepare and validate study data and reports.
Integrity, Reliability, Objectivity, Trust
The MREF can offer clients the necessary technical knowledge, depth and breadth of staffing resources, experience in relevant technical areas, and eagerness to work in partnership with clients to deliver solutions to the most critical scientific and technological challenges. Access to the MREF resources and capabilities means reduced technical, schedule, and cost risk for clients:
