Biomarkers are playing an ever-increasing role in the discovery and development of drugs, and many companies are relying on biomarker data to make critical decisions regarding compound selection and product development at all stages of development. Our biomarker teams utilize the latest scientific innovation and state-of-the-art platforms to generate the highest quality data in support of both preclinical and clinical studies in various therapeutic areas. Spanning all phases of drug development, our experts work closely with our clients to design and perform biomarker analysis customized to each development need. Our team’s proficiency in this field enables them to provide the most relevant experimental results to assess the functional activity of each compound and biologic.
Here at Alliance Pharma, we have industry-recognized expertise in biomarker assay method development, transfer, and validation using both LC-MS/MS and ligand binding assay (LBA) platforms. Our LBA team also frequently adapts commercial kits to support well characterized biomarkers. Our specific platforms include:
HPLC / UHPLC-MS/MS
- SCIEX API 4000™, 5500, 6500, and 4000 QTRAP,
- Thermo Scientific™ Q Exactive™ Plus
- Thermo Scientific™ Orbitrap™ (XL)
- Agilent 6545XT AdvancedBio LC/Q-TOF
Ligand Binding Assays (singleplex and multiplex formats)
- Cell-based assays
Alliance Pharma is a CLIA-certified(1) COLA-accredited(2) laboratory and supports clinical research by providing a resource to perform diagnostic biomarker testing at all phases of clinical development.
Our expertise includes regulated (GCP & GLP) and R&D support through all phases of clinical development (Phase I, II, II, IV), customized method development and fit-for purpose assay validation, transfer of proprietary assays, adaptation of commercial kit-based assays, and sample analyses. For a full list of assays that demonstrate our wide range of experience and expertise, please visit our website. You can request a quote and contact us directly through our website as well. We look forward to hearing from you!
(1) CLIA refers to the Clinical Laboratory Improvement Amendments program, administered by the Centers for Medicare and Medicaid Services (CMS), which provides regulatory guidance for quality laboratory testing.
(2) COLA is an independent, non-profit accreditor, recognized by CMS, whose education-based program and standards enable clinical laboratories and staff to meet CLIA and other regulatory requirements.