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