Instrumentation

BioAgilytix leverages the Meso Scale Discovery^® (MSD) platform’s plate-based electrochemiluminescence (ECL) technology to provide reliable, accurate data for a variety of bioanalytical assays.

BioAgilytix offers real-time PCR (also known as quantitative PCR or qPCR) and Droplet Digital PCR (ddPCR) platforms as part of our extensive technology suite supporting molecular assays. Our molecular laboratories are equipped with the latest generation of PCR equipment including Applied Biosystems QuantStudio 7 Flex or Pro with both 96- and 384-well fast-cycle options and TaqMan Array Cards for qPCR as well as QX200 and QX ONE ddPCR Systems from Bio-Rad.

BioAgilytix uses Luminex’s innovative bead-based technology to perform many immunoassays under nonregulated and GxP conditions. We operate Luminex FLEXMAP 3D^® systems at multiple locations globally with xPonent software that is 21 CFR Part 11 compliant for our regulated assay support. We maintain several data analysis software options as well to provide versatility during the drug development process.

The LI-COR Odyssey Western blot delivers quantitative results for target protein detection using the platform’s infrared technology. This can improve on the sensitivity achieved using traditional chemiluminescent detection systems. BioAgilytix performs accurate, reproducible, quantitative Western blot assays leveraging this platform.

BioAgilytix offers Ella™, from ProteinSimple^®, a Bio-Techne^® brand, as part of our extensive technology suite supporting complex biomarker work. Our scientists typically turn to Ella for multiplex biomarker analysis in cases where assay variability and antibody cross-reactivity are of particular concern. This platform standardizes sample preparation to ensure each assay is consistently and reproducibly run.

Enabling label-free interaction analysis, the Biacore platform delivers data with rich content on biomolecular interactions. BioAgilytix offers the Biacore™ T200 to deliver highly specific analysis, robust data quality, and efficient time-to-results for immunogenicity studies at any phase of development.

BioAgilytix offers Enzyme-Linked Immunosorbent Spot (ELISpot) assays at multiple global locations. With the ability to qualify and validate assays for nonregulated or regulated work, BioAgilytix’s ELISpot platform provides robust data for monitoring cell-mediated immune responses to biologics, cell therapies, and gene therapies during clinical and preclinical testing.

Enzyme-linked immunosorbent assays (ELISA) are the most common method for ligand-binding assays and a core competency for the BioAgilytix team. We use ELISA in both its original and automation-powered forms as a fast, reliable, and cost-effective platform for analyte quantification to support bioanalysis across all modalities and analyses, including pharmacokinetics, anti-drug antibody, and biomarkers.

Designed for both quantitative and qualitative in vitro assay determinations, the Roche Cobas^® e 411 analyzer enables BioAgilytix to support immunoassay analysis for a broad range of applications, from biomarker work to infectious disease testing. The analyzer’s ECL technology is highly sensitive, yielding reliable, reproducible results for heterogeneous immunoassays. BioAgilytix also uses the Roche Cobas^® c 311 analyzer for clinical chemistry testing.

The ImmunoCAP platform is used to measure total or specific IgG and IgE antibodies in samples. BioAgilytix offers ImmunoCAP assay development and testing services at our laboratory in Hamburg, Germany, to deliver reproducible results.

BioAgilytix uses the Gyros platform to perform immunoassays using this proprietary microfluidics system. Immunoassays on the Gyrolab generate quick, reproducible results using much smaller sample volumes than traditional ELISA techniques. Gyrolab automates robust immunoassays run with identical microfluidic channels using highly sensitive, laser-induced fluorescence (LIF) detection.

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.

Flow cytometry is an accurate and effective method when used to identify and measure cellular biomarkers in complex subpopulations.