Pharmacokinetic Profiling

This service is provided by the Biomarkers Core Laboratory.

Overview

The Biomarkers Core Laboratory (BCL) provides expert guidance and technical support for the development and validation of LC-MS/MS assays across all stages of drug development. Our work supports studies in absorption, distribution, metabolism, and excretion (ADME) as well as pharmacokinetics and pharmacodynamics (PK/PD) in both preclinical and clinical settings. We specialize in developing novel, customized LCMS-based assays that strictly follow FDA guidelines to quantify drugs and their metabolites in various biological matrices, supporting both small molecule drug monitoring and emerging therapeutic development.

Our portfolio includes several Anticancer/Chemotherapy Agents (Ricolinostat, Ibrutinib, Pralatrexate, Romidepsin, Cabazitaxel, Clofarabine, Bortezomib etc), antiviral agents (emtricitabine/tenofovir), contraceptives (Etonogestrel, Levonorgestrel, Ulipristal acetate), anesthetics (Ketamine, Midozolam), opioids and cannabinoids.

The drug monitoring assays are set up on a LC-MS/MS platform using customized sample preparation protocols and multiple reaction monitoring (MRM) under positive or negative electrospray ionization mode, depending on the chemical characteristics of the compounds. Drug quantitation is based on external reference standards and stable isotope labeled (13C, 2H) internal standards.

Instrumentation

At BCL, Agilent 6410A mass spectrometer coupled with Agilent 1290 Infinity UHPLC serves as a robust platform for pharmacokinetic profiling assays. Agilent 6410 is known to deliver reliable performance, sensitivity and throughput necessary for quantitative applications in ADME/PKPD studies and biomarker validation in clinical research.

Instrumentation

At BCL, Agilent 6410A mass spectrometer coupled with Agilent 1290 Infinity UHPLC serves as a robust platform for pharmacokinetic profiling assays. Agilent 6410 is known to deliver reliable performance, sensitivity and throughput necessary for quantitative applications in ADME/PKPD studies and biomarker validation in clinical research.

Hours

The BCL is open Monday – Friday, 9am to 5pm. Samples may be dropped off during these hours and dry ice must be used during transportation.

Eligibility and Requirements

Pharmacokinetic profiling services are available to all researchers at Columbia University and at other academic institutions. 

Investigators who are not affiliated with Columbia University will need to complete a service agreement that must be signed by the legal or purchasing departments of both parties. This process takes approximately four weeks to finalize. The requester's legal or purchasing department’s service agreement template is typically used, but one can be provided by Columbia if necessary. For more information on service agreements and pricing for non-CU initiated studies, please email the BCL director, Dr. Renu Nandakumar.

The BCL is not Clinical Laboratory Improvement Amendments (CLIA)-certified. The data generated from BCL is to be used for research purposes only and not for clinical and diagnostic applications.

Submitting Requests

A new protocol submission request must be initiated in iLab for every new project. Samples will not be accepted without an active service request. Additional request details forms must be submitted if more assays or samples need to be added to an existing protocol. Please contact us for the instructions on how to register and submit a service request through iLab.

Sample Submission

Please review the BCL’s User Policy and General Sample Submission Guidelines prior to submitting the samples and complete the downloadable sample list template to be delivered along with your samples.

When to Request This Service

We strongly encourage investigators to contact BCL director, Dr. Renu Nandakumar, prior to submitting a new service request. This will facilitate a discussion on the project, scope, feasibility, appropriate analytical strategy and other sample requirements.

Cost

A complete list of the mass spectrometry-based assays including drug monitoring assays and associated cost is available on our iLab site.

Cite it, Submit it, Share it!

If your research has benefited from one or more Irving Institute resources, please remember to:

• Cite our CTSA grant, UL1 TR001873, in any relevant publications, abstracts, chapters, and/or posters.
• Submit your publications to PubMed Central (PMC) for compliance with the NIH Public Access Policy.
• Share your research updates with us by sending an email to: irving_institute@cumc.columbia.edu