The Preclinical Studies Program at the Keeling Center serves MD Anderson and other investigators who are developing novel therapeutics and require Good Laboratory Practice (GLP)-compliant toxicology and safety studies to support Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) so that testing in human clinical trials can begin. More than 50 faculty and staff certified in their specialty areas from across the Keeling Center support the Program. The Keeling Center's laboratories, animal facilities, and clinical veterinary components are validated for GLP and have been inspected/audited numerous times by the FDA and outside study sponsors. The laboratories are compliant with the Code of Federal Regulations, 21 CFR Parts 58 and 11. An independent, on-site Quality Assurance Unit (QAU) reporting directly to the Keeling Center Director monitors the Program and each individual GLP study.
Service offerings include:
- Planning, design, implementation, and management of on-site nonclinical laboratory study protocols.
- Clinical Pathology Laboratory Services: serum chemistry, hematology, coagulation analysis, urinalysis, microbiology, parasitology, and serologic analyses.
- Anatomical Pathology Laboratory Services: necropsy, histopathology, and immunohistochemistry.
- Environmentally controlled storage of study data, reports, and tissues.
- On-site information technology to maintain a controlled and validated electronic records environment.
The Anatomic Pathology Section provides comprehensive diagnostic, collaborative, and research-related pathology services and a tissue/biological fluids banking program. Capabilities include necropsy and histopathology services. In addition, the Section conducts FDA-regulated, Good Laboratory Practice (GLP)-compliant nonclinical studies in support of cancer drug development. The staff consists of three board-certified veterinary anatomic pathologists (ACVP) and three certified histotechnologists (ASCP).
The diagnostic laboratory provides traditional laboratory services in the areas of hematology, coagulation, clinical chemistry, microbiology, serology, parasitology, and molecular diagnostics (PCR). The support staff consists of seven medical professionals: five medical technologists (four of whom are certified by the American Society of Clinical Pathologists) and an AALAS LATG-certified animal resources technologist who supports tissue and biological fluid collection and banking.
The clinical pathology laboratory is a validated, Good Laboratory Practices (GLP)–compliant facility. It has been inspected by the U.S. Food and Drug Administration and is frequently audited by outside study sponsors. All laboratory services are conducted under the supervision of a veterinary clinical pathologist.
The Keeling Center is a longtime provider of biological and in vitro products to state and federal government institutions, contract research organizations, as well as diagnostic and academic facilities. We specialize in animal whole blood, plasma, serum, tissues and other products that may be required for clinical testing and research diagnostics.
We work to tailor the collection of biological matrices to meet our customer’s needs including anticoagulant selection, donor population identification, matrix collection protocols and diagnostic testing. In addition to blood products, other biological materials and tissues may be obtained as requested. The following species are maintained onsite and are readily available for collection:
- Nonhuman Primate
Request biological resources with our Biologics Request Form.
Clinical Laboratory Services
The Keeling Center offers a complete range of clinical pathology laboratory services to support research animal models, discovery research, preclinical studies and/or clinical trials. Our clinical pathology laboratory is staffed by Registered Clinical Laboratory Scientists and laboratory animal specialists with extensive knowledge of animal and human clinical laboratory services. Our state-of-the-art laboratory can support all stages of human and veterinary drug development, and we conduct testing in accordance with the current standards for Good Laboratory Practices (GLP).
Services available include:
- Coagulation profiles
- Hematology testing
- Serum Chemistry
Infectious Disease Services
The Keeling Center utilizes a wide variety of animal models in its drug discovery and Preclinical research programs. Our Infectious Disease Testing Services are built upon a foundation of contamination prevention measures, effective pathogen detection, and scientific and technical proficiency. The cornerstone of this program is our diagnostic laboratory that delivers sensitive and specific testing to screen animal facility, research biologics and a wide variety of research animal models, including mice, rats, and nonhuman primate species.
- Enteric pathogen screening
- Respiratory pathogen screening
- Culture of wounds, etc.
- Antibiotic sensitivity testing
- Water testing for heterotrophs and coliforms
- RODAC plate testing
Molecular Diagnostic Testing (PCR)
- Enteric PCR Screening
- Sterility Checks of Cell Cultures and Antibodies
- New World Monkeys
- Old World Monkeys
- Fecal Centrifugation and Concentration (FCC)
- Occult Blood testing
- Trichrome staining
The (Advia 120) hematology analyzer performs cell counts of whole blood to include White Blood Cells, Red Blood Cells, Hemoglobin and Platelets.
Microbiology is performed on various types of samples to identify bacteria associated with infection or clinical obersvations.
Small sections of tissues are prepared for cutting using an embedding center. The cut tissues are then prepared for our pathologists to review.
Pathologists review blood and cytology smears, as well as histology slides to determine a diagnosis.