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Bioanalytical CRO Services

As one of the world's leading bioanalytical contract labs, we specialize in research services to support you throughout all stages of the drug development process. With a focus on personalized service, you receive expert consult through one point of contact during your entire project.

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Small Molecule Bioanalysis

Specializing in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using regulated and non-regulated LC/MS/MS, HPLC/UV, and HPLC/Fluorescence.

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Large Molecule Bioanalysis

We perform immunological ligand-binding assays (LBA) and enzymatic assays to support sample analysis for large molecule drugs (e.g., biologics), anti-drug antibodies (ADA), and biomarkers (e.g., cytokines) in regulated and non-regulated drug development studies. Our primary analytical platforms include ELISA, Meso Scale Discovery (MSD) electrochemiluminescence (ECL), and multimode fluorescence (fluorescence intensity, time resolved fluorescence, and fluorescence polarization assays).

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Specimen Collection Kits

Assembly and distribution of protocol-specific specimen collection kits to streamline the PK collection process for single and multi-site clinical trials. Kits are tailored to your specific sampling needs.

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DMPK Assays

Industry-standard drug metabolism assays, custom research, and IND-enabling studies to assess drug-drug interaction potential, metabolic stability, metabolite profiling, and protein binding.

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Method Development and Validation

Method Development, GLP method validations, and method transfers for small and large molecule drugs, protein and other types of biomarkers, and peptides using LC/MS/MS, HPLC/UV, HPLC/fluorescence, immunological ligand-bindings assays, as well as enzymatic activity methods. All performed in accordance with USFDA standards, and any other regulatory agencies, as required per protocol.

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Pharmacokinetic Analysis and Reports

Pharmacokinetic (PK) and toxicokinetic (TK) data analysis for discovery, preclinical, and clinical studies. We perform model dependent or model independent analyses to calculate bioequivalence, drug exposure, and drug data recovery.

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Protein Binding Assays

Determine the extent of drug binding to plasma and/or tissue proteins during the drug development process. We measure drug-protein binding characteristics to develop a specific and sensitive quantitative method.

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Dose Formulation Analysis

High quality analysis of preclinical dose formulations for GLP and non-GLP toxicology studies. We conduct formulation sample analysis to assess stability, homogeneity, and to discover solubility issues.

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Biomarker Assays

Biomarker assay development, validation, and profiling of biomarker panels, using LC/MS/MS, single or multiplex ligand-binding assays (MSD, ELISA, fluorescence), and enzyme activity techniques.

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Biomarker Analysis by LC/ MS/MS

Optimizing enzymatic digestion to create a stable derivative enabled us to develop an LC/MS/MS method to measure concentrations of a key biomarker directly related to the activity of a biologic.

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“BioAgilytix has saved the day several times, with more than one client. Their analytical team has been able to resolve bioanalytical issues for very tricky drugs. Other labs had tried and failed – BioAgilytix had it figured out in a few days. They seem capable of doing what other labs cannot.”

- Consultant, Preclinical Safety
Worked with BioAgilytix since 2012

Ready to Start Your Project? Have a Question?

Our scientists are available to discuss how our bioanalytical CRO can help you streamline the drug development process through specialized expertise in regulated bioanalysis, DMPK, and pharmacokinetic analysis.

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