For Small and Large Molecule Bioanalytical Testing.
BioAgilytix provides Liquid Chromatography-Mass Spectrometry (LC/MS) support to perform bioanalytical testing under both nonregulated and GxP conditions. We operate large and small molecule assays using advanced instrumentation and software that is 21 CFR Part 11 compliant for our regulated assay support. We maintain several other data analysis software options as well to provide versatility during the drug development process. Our facilities are located at multiple global locations and boast spacious, custom-designed LC/MS laboratories with state-of-the-art unit mass and high-resolution mass spectrometers to support drug discovery and development programs.
BioAgilytix’s expertise with LC/MS bioanalytical solutions
Our scientists are experienced with developing and implementing bioanalytical LC/MS assays across a range of matrices including liquid, non-liquid, and rare biomatrices. These techniques include the use of various cleanup methods and sample extractions which are performed using the latest LC/MS equipment and are scalable to meet the demands of each project, including handling of high-volume studies within defined timelines.
Our team of LC/MS experts are deeply engaged in the process of working with our clients to determine the technical and regulatory considerations for each project that can drive the overall methodology and define regulatory requirements. We are staffed with dedicated LC/MS scientists that are well-versed in the unique challenges and considerations for these types of assays. At BioAgilytix, we pride ourselves in our established team of experts who are ready to collaborate with our clients at all stages of the drug development process to design appropriate, scientifically rigorous LC/MS solutions.
Laboratories designed for your LC/MS applications
BioAgilytix leverages LC/MS techniques in our work with biomarkers, pharmacokinetics/toxicokinetics, pharmacology, drug-drug interaction, bioequivalence/bioavailability, and immunogenicity bioanalysis across an array of therapeutic modalities and drug development applications. Our state-of-the-art systems allow us to provide specific, robust bioanalytical solutions for our clients.
- Sciex QTRAP 5500/TripleQuad 5500/API 4000
- Waters Xevo TQ/TQ-S/TQ-S Micro
- Waters Quattro Premier/Quattro Micro/Quatro Ultima
- Sciex Triple Quad™ 7500 LC-MS/MS with Exion 2.0+ UHPLC
- Thermo Scientific Orbitrap Exploris™ 240 with Vanquish Flex UHPLC
- Sciex Triple Quad™ 7500 LC-MS/MS with Exion 2.0+ UHPLC
- Thermo Scientific Orbitrap Exploris 240 with Vanquish Flex UHPLC
- Waters Xevo TQ-S LC-MS/MS System with Acquity UPLC
- Thermo Scientific KingFisher Flex System
- Hamilton liquid handling system
- Viaflow multi-well plate pipetting system
LC/MS platform use in bioanalysis
Liquid Chromatography-Mass Spectrometry (LC/MS) is a technique that involves the physical separation of target compounds by liquid chromatography (LC) followed by mass-based detection of charged ions using mass spectrometry (MS). By combining these processes together, LC/MS can produce data about the weight, structure, identity, and/or quantity of the analytes of interest in a sample. LC/MS is widely accepted as the go-to method for quantitation and identification of small molecule drugs and metabolites. However, the application of this technique to large molecule assays has become more and more common.
Large molecules have traditionally been analyzed using ligand-binding assays (LBAs). However, LBAs often fail to provide necessary sensitivity and selectivity for protein therapeutics with endogenous components, metabolites, post-translational modifications, or conformational changes that interfere with the assay read out. LC/MS has emerged as a solution to these problems. In addition to large molecule quantification, LC/MS has become a useful alternative for immunogenicity testing such as anti-drug antibody (ADA) assays when there are specific factors preventing a traditional LBA approach or leading to superior performance of an LC/MS-based technique.
Advantages of LC/MS in Large Molecule Bioanalysis
- No antibody – no problem: no custom reagents required
- Multiplexing: multiple targets including metabolites in one assay
- Timeline friendly: rapid method development
- Large assay dynamic range
- Can distinguish isoforms/PTMs
- High selectivity (can distinguish drug from endogenous proteins)
Speak to a scientist today
Learn more about how BioAgilytix can help you reach your discovery drug development goals