The Clinical Pharmacology Analytical Laboratory (CPAL) is located within the Division of Clinical Pharmacology in the Department of Medicine within the Johns Hopkins University School of Medicine. The CPAL provides robust bioanalytical methodologies to support a wide variety of pharmacologically-driven research. The operations of CPAL are conducted both at the Johns Hopkins Hospital East Baltimore Medical Campus (EBMC) as well as the Mason F. Lord Center Tower at the Johns Hopkins Bayview Medical Center (BMC).

The CPAL has expertise in the pre-analytical, analytical, and post-analytical stages of the total testing process. The laboratory specializes in the development, validation, and implementation of bioanalytical tools to support pre-clinical and clinical trials.  The CPAL contains a dedicated specimen processing area, for the receipt and pre-analytical management of a variety of specimen sources. The laboratory has the capability to process and store blood samples, isolate peripheral blood mononuclear cells, and manage a variety of alternative specimen sources. Biological instrumentation within the laboratory include a gamma counter, a liquid scintillation counter, and a Guava® EasyCyte Plus System flow cytometer. The CPAL is equipped with several BSL2 laboratories that facilitate bioanalytical activities. 

The CPAL also specializes in the quantification of small molecules using liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analyses. Currently, the laboratory contains 6 LC-MS/MS systems that are used to support clinical research trials.  Assays are validated in accordance with the FDA, Guidance for Industry: Bioanalytical Method Validation recommendations.  Instrumentation included in the bioanalytical core include 6 SCIEX API mass spectrometers (2x API4000,1 API4500,1 API5000,1 API5500, 1 API6500), five Waters Acquity ultra performance LC systems and two Shimadzu LC systems. The laboratory is also equipped five -80°C freezers, and two -20°C freezers for both short-term and long-term specimen storage. Current research focuses of the CPAL is in the development and implementation of analytical assays to assess the compartmentalized pharmacokinetics of anti-infective agents in the prevention and/or management of HIV/AIDS and tuberculosis (TB).

The CPAL is directed by Mark Marzinke, PhD, DABCC. For testing requests or collaborations, please contact Dr. Marzinke at [email protected].

Oversight

The CPAL participates in the HIV/AIDS Clinical Pharmacology Quality Assurance (CPQA) program administered by the UB Pharmacotherapy Research Center of the University at Buffalo (UB).  The CPQA program provides quality review of assay validation reports (AVRs) and Method Standard Operating Procedures (SOPs) for Pharmacology Specialty Laboratories (PSLs).  Refer to the CPQA website for additional information.