Bioanalytical Testing & LC/MS/MS Analysis

Liquid chromatography – tandem mass spectrometry (LC/MS/MS) and Immunoaffinity LC/MS services for the quantitative determination of small molecule, peptide and macromolecule therapeutics in support of pharmacokinetic (PK) studies.

Tailored solutions for small molecule, peptide and proteins

As a key methodology in today’s PK studies, we offer a number of bioanalytical testing services in support of your trial, including tailored Liquid chromatography-mass spectrometry (LC/MS). Our highly experienced staff utilizes leading-edge technology including AB SCIEX™ / Thermo Scientific triple quadrupole mass spectrometers, Thermo Scientific High Resolutions mass spectrometers, and state-of-the-art extraction techniques. 

We are one of the few bioanalytical laboratories successfully employing immunoprecipitation techniques and multi-dimensional Liquid chromatography for the quantitation of biotherapeutics, peptides, proteins, and biomarkers. Our team has the experience and knowledge in development and validation of small and mid-size peptides to proteins, fusion proteins and monoclonal antibodies. The development of these assays is followed by method validation and sample analysis consistent with global regulatory requirements and governed by SOPs.  

Our LC/MS/MS solutions include:
  • Sample analysis for clinical and non-clinical studies (Discovery through Phase IV clinical studies).
  • Bioanalysis of small molecule drugs and their metabolites in support of PK investigations.
  • GLP compliance in support of FDA, OECD, and MHLW regulations.
  • Bioanalytical methods development and validation.
  • 96-well sample processing and analysis.
  • Multiplex Liquid chromatography-mass spectrometry.
See our validated bioanalytical methods list. 

Delivery excellence

In addition to the solutions we offer, our customers can expect superior service and the highest quality results during routine as well as non-routine projects.   We have multiple sites within the US to support your study across a large geographical region.  Q2 Solutions bioanalytical Liquid chromatography-mass spectrometry capabilities and work in the US are managed from two lab locations - Ithaca, New York, which focuses on discovery, preclinical, and clinical bioanalytical testing; and, Indianapolis, Indiana, which is home to our ADME services team.   

Beyond some of the latest chromatography systems our team implements a diverse mix of technologies and processes to deliver timely, high quality results.
  • Watson-LIMS® data management and sample tracking
  • Linear and 2D barcode tracking
  • Integrated Sample Management Services (sampling material assembly, distribution, and tracking)
  • Electronic Lab Notebook (Perkin-Elmer)

Shaping outcomes

Our scientists have extensive expertise inbioanalytical testing, method development and Liquid chromatography – tandem mass spectrometry to not only meet your analytical needs but to bring insights to the table that enhance the drug development process.  

Learn more about our bioanalytical capabilities including our biomarker and immunoassay  services
Bioanalytical Method Development & Validation of a Trapping-Nano-Hybrid LBA/LCMS method for Clinical Studies

Recent Application of Highly Sensitive Methods for Quantitation of Biotherapeutics in Regulated Bioanalysis

Q2 Solutions Biomarker Services

Providing tools and experience to maximize your biomarker strategy

Mass Spectrometry to Enable Sensitive Quantitation of a Small Molecule Therapeutic

Overcoming Triple Quadrupole Selectivity Challenges by Use of High-Resolution Accurate Mass Spectrometry to Enable Sensitive Quantitation of a Small Molecule Therapeutic in Rabbit Plasma

Q2 Solutions Central Laboratory Services

Optimized logistics, deeper science, better insights

Quantitative Measurement of a Candidate Antibody Therapeutic in Human Plasma by LC/MS/MS using Formic Acid Digestion

Demonstration that a 2% formic acid digestion can produce a selective signature peptide for antibody quantification using nano-LC/MS/MS

Unifying Processes to Measure Entecavir in Human Matrices in Two Geographically Distinct Laboratories

Transfer of an assay between Europe and North America

Using Cyclic Nucleotides to Assess Endogenous Dilution Accuracy as a Measure of Biomarker Selectivity in LC/MS/MS

Accurate measurements of cAMP and cGMP as a useful biomarkers for development of therapeutics for a variety of indications

Read More