Core Facility Information
Dr. Maponga and students work on a Mass Spectrometer
The UB HIV and HCV Clinical Pharmacology Laboratory is an internationally recognized leader in antiviral pharmacology and therapeutics and has been conducting antiviral research since the beginning of the HIV epidemic.
The TPRC was one of the initial National Institutes of Health Pharmacology Specialty Laboratories funded through the University of Rochester (UR) Clinical Trials Unit when the AIDS Clinical Trials Group (ACTG) was established. The laboratory is a training site for numerous national and international faculty, pre-doctoral students, postdoctoral fellows and residents. The international HIV and HCV clinical pharmacology research and training is supported by NIH funding for the NIAID HIV Clinical Pharmacology Quality Assurance Program, the NIAID AIDS Clinical Trials Group Pharmacology Specialty Laboratory and an HIV Training and Research Program (HTRP) in Clinical Pharmacology with the University of Zimbabwe from the Fogarty International Center.
The UB HIV and HCV Clinical Pharmacology Laboratory provides international and national leadership through IAS faculty membership; editorial board activity for www.Antimicrobe.org; chair for the ACTG Clinical Pharmacology Laboratory Core; membership on ACTG Transformative Sciences Group; chair, Annual HIV Clinical Pharmacology Capacity Building Symposium at IAS and Co-Director, SUNY Global Health Institute.
As one of the leading antiviral pharmacology programs, we are focused in the following areas:
- Conducting innovative HIV and HCV clinical and translational research.
- Investigating novel biomatrices and compartments for the measurement of antiviral activity.
- Integrating pharmacokinetics and pharmacodynamics with human and viral genomics and proteomics to facilitate and accelerate drug development research.
- Promoting capacity building to train translational scientists and build global research infrastructure for antivirals and associated co-infections.
Our laboratory provides a global antiviral proficiency testing program through an NIH contract and conducts laboratory site assessments as a component of research quality assurance and capacity building. We also are the PIs for the NIAID Precautionary and Prohibited Medications Database, a resource for NIH investigators designing protocols for antiviral drug development.
Equipment and Laboratory Information
The primary analytical equipment used to quantitatively measure drugs, their metabolites, and other small molecules incudes Waters Aquity Ultra-performance Liquid Chromatography units equipped with both photodioide array and TQD triple quadrupole mass spectrometers. These units are programmed using Water’s Empower software, maintained under manufacturer contracts and protected by uninterruptible power supply units. Older chromatography equipment is maintained for the purposes of education and training.
To prepare biological samples for analysis, the laboratory is equipped with a biological safety cabinet, chemical fume hoods, nitrogen evaporators, various centrifuges, analytical balances, a spectrophotometer, pH meters, and other small equipment to support the laboratory work. Additionally, specialized equipment such as a Next Advance bead homogenizer is available to prepare tissue and other non-traditional samples for bioanalysis. All equipment is calibrated and maintained as required.
Equipment for genomics and molecular diagnosis includes 7300 real-time PCR system, Bio-Rad Western blot, a temperature-controlled plate reader for enzyme immunoassay, and regular PCR. All analytical systems are fully automated, networked and controlled by data processing software programs. All computers are networked for electronic download of results from the instrumentation into database specific study files.
Genomics Equipment:
- 7300RT-PCR System
- Thermal cycler TC-50A
- Trans-Blot SD System and Powerpac HC Power supply
- BSL-2 certified laboratory with back-up generator power, instrument data ports, house air, deionized water, bio-safety cabinet. Precision incubators, refrigerators and freezers, microcentrifuges, centrifuge, spectrophotometer, microscope, computerized syringe pump, computerized peristaltic pumps, Duet hollow fiber pump and magnetic heat/stir plates.
The TPRC laboratory operation has a quality assurance program that monitors all laboratory resources (including human resources), facilities and equipment, policies and standard operating procedures, quality assurance and improvements, pre-analytical, analytical and post-analytical operations, to comply with NYSDOH and CLIA requirements. All activities are documented and operate closely with GLP standards. The TPRC laboratory’s analytical chromatographic equipment, electronic systems and software are maintained by manufacturer and servicer contract agreements. The TPRC laboratory utilizes the university’s Environment, Health & Safety department for the inspections of chemical fume hoods, and an outside company for biological safety cabinets and freezers, as well as other equipment not covered under warranties.
All methods for clinical specimen bioanalysis are developed and validated in accordance with the FDA’s bioanalytical guidance and currently accepted bioanalytical white papers. Methods are reviewed by outside reviewers to assure that the validation data meets requirements for accuracy, precision, selectivity, specificity and stability.
The TPRC laboratory is staffed with highly trained and experienced scientific and support personnel, including NYSDOE-certified Medical Laboratory Technologists and Technicians. The TPRC staff are regularly trained in safe laboratory practices, including biological safety, chemical safety and chemical hazardous waste handling and disposal.
Quality Assurance
The TPRC laboratory operation has a peer quality assurance program that reviews all analytical procedures to comply with NYSDOH and CLIA requirements and operates closely with GLP standards. The TPRC laboratory’s analytical chromatographic equipment, electronic systems and software are covered under maintenance contract agreements. The TPRC laboratory utilizes the university’s Environment, Health & Safety department for the inspections of chemical fume hoods, and an outside company for biological safety cabinets and freezers, as well as other equipment not covered under warranties.
The TPRC laboratory is staffed with highly trained and experienced scientific and support personnel, including NYSDOE-certified Medical Laboratory Technologists and Technicians. The TPRC staff are regularly trained in safe laboratory practices, including biological safety, chemical safety and chemical hazardous waste handling and disposal.