Small and Large Molecule LC-MS

Liquid chromatography-mass spectrometry (LC-MS) is an essential technique for the modern bioanalyst. It has decades of precedence in small molecule drug development and regulated bioanalysis. As such, pharmacokinetic studies of small molecule drug candidates typically use LC-MS. Of late, the application of LC-MS has expanded to mid-sized drug modalities (e.g., peptides, small proteins, lipids and oligonucleotides) and large biotherapeutic drugs (e.g., antibodies and antibody-drug conjugates). We also now encounter LC-MS quantitative bioanalysis being applied to matrix-endogenous compounds including biomarker studies. With over 30 years’ experience serving the bioanalytical needs of our clients, IQVIA Laboratories has built operations that meet the needs of this rapidly changing drug development arena.

Our Project Managers and Principle Investigators have years of experience understanding the specific nuances of regulated bioanalysis that apply to your bioanalytical programs. With a stellar regulatory record, our LC-MS laboratories conduct bioanalysis to GLP/GCP regulations while in accordance with internationally recognized ICH M10 guidance for bioanalytical method validation.    

Whether you need support for an early preclinical study with 200 samples or a clinical Phase III or bioequivalence program with 30,000 samples and fast data turnaround, we have built our services to help you deliver to plan. 

Small Molecule Regulated Bioanalysis by LC-MS

Triple quadrupole mass spectrometry coupled to liquid chromatography is the mainstay of small molecule quantitative bioanalysis. IQVIA Laboratories’ bioanalytical laboratories have been leaders in the application of these LC-MS technology developments since 1993 and continue to serve our clients across the drug development spectrum as experts in the field.

We have over 60 modern triple quadrupole LC-MS systems dedicated to small molecule bioanalysis applications. These mass spectrometer instruments are matched with laboratory functions and operations that support PK/PD study bioanalytical work compliant with GLP/GCP regulations and global bioanalytical guidance from around the world.   

IQVIA Laboratories has extensive experience in de novo assay development, method transfers, method validation and in-study samples analysis supporting pre-clinical, non-clinical and clinical bioanalytical programs. From relatively simple small molecule drugs to peptide drugs, oligonucleotides, lipids and antibody conjugated payload moieties we apply our expertise to generating regulatory submittable bioanalytical data. Our laboratories are outfitted with a full suite of sample preparation equipment including robotic handling automation and 96-well plate standardization for biological fluid and tissue pre-treatment.

Small molecule LC-MS bioanalysis has continuously evolved since its inception and with techniques such as dried matrix microsampling, heavily multiplexed assays, biomarkers, new drug modalities and advances in drug formulation, IQVIA Laboratories continues to practice at the frontiers of bioanalysis with industry leading service and science.

Large Molecule Regulated Bioanalysis by LC-MS

Formed in 2008, the LC-MS Biologics team at IQVIA Laboratories utilizes both triple quadrupole and High Resolution Mass Spectrometry (HRMS) for biological analyte LC-MS quantitation.  With a fleet of 11 validated HRMS comprised of both Q Exactive^TM Orbitrap and Orbitrap Exploris^TM instruments, we lead the industry with HRMS capacity for regulated bioanalysis. 

With the increasing need for sensitive bioanalytical methods, we have a fleet of nano-flow liquid chromatography systems which when coupled to high resolution mass spectrometers provide ultimate sensitivity. Extensive HRMS and low flow chromatography capabilities along with automated bead-based immunoprecipitation techniques delivers unparalleled sensitivity and proven reproducibility in robust workflows. These advanced techniques and our depth of experience combine with a collaborative approach to solve your large molecule bioanalytical challenges.