Bioanalytical LC/MS/MS

Quintiles’ bioanalytical lab specializes in liquid chromatography – tandem mass spectrometry (LC/MS/MS) services, with industry recognized expertise in bioanalytical methods development. Our clients include the largest pharmaceutical companies as well as many smaller specialty pharmaceutical and biotech companies.

banner_blue testing

100% of 2013's best selling products or compounds

Quintiles has helped develop or commercialize 100% of the top 100 products or compounds in 2013.

Small Molecule, Biologic and Biosimilar Expertise

Our scientists have extensive bioanalytical method development and LC/MS/MS expertise to meet study needs. Highly trained staff utilizes leading-edge technology including AB SCIEX™ mass spectrometers and state-of-the-art extraction techniques. Clients experience superior service and results during routine as well as non-routine projects.

We are one of the few bioanalytical laboratories successfully employing immunoprecipitation techniques and multi-dimensional (up to 3-D) LC for the quantitation of biotherapeutics and biosimilars drugs. 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 services 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
  • Bioanalysis of biotherapeutics and biosimilars 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
  • Watson-LIMS® data management and sample tracking
  • Linear and 2D barcode tracking
  • Integrated Sample Management Services (sampling material assembly distribution, and tracking)
  • A wide range of validated bioanalytical methods 

Our 33,000-sq. ft. bioanalytical CRO facility includes:

Four wet laboratories as well as facilities for working with radiochemicals (3H and 14C)

References:  Critical topics in ensuring data quality in bioanalytical LC–MS method development Mulvana, D.Bioanalysis, 2010 Jun:2(6):1051-1072.

Proof in marketplace

Our Bioanalytical Labs have an excellent record of successful regulatory inspections from the FDA, EPA, and large pharmaceutical clients.

Related Services

Biomarker Services
Early Clinical Development
Central Laboratories