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Strategies for bioanalytical method development & validation

Eurofins Clinical Trial Solutions
20 Jan 2025
Charlie Carter
Life Sciences Editor
Strategies for bioanalytical method development & validation

Erik Jerks, Director, Bioanalytical Sciences and Service at Eurofins, discusses strategies for bioanalytical method development and validation, highlighting Eurofin's expertise in bioanalytical assays for biologics. The video covers three case studies that address challenges in assay development for bispecific multitarget antibodies and adeno associated virus (AAV)-based drugs. Here, Jerks underscores the importance of evolving technologies and robust automated instrumentation in tackling bioanalytical challenges from multiple angles, ultimately delivering high-quality solutions tailored to client needs. Download the free handout for further detail or contact: ClinicalTrials@VBP.EurofinsUS.com​ for further information.

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Eurofins Clinical Trial Solutions

Complex innovative clinical trial designs require an integrated synergetic approach to assess novel drug compounds for safety and effectiveness which often span esoteric, regulated and safety outcomes in all phases of the drug development life cycle. The companies of Eurofins Bioanalytical Services, the Eurofins Central Laboratory global network, Eurofins Viracor BioPharma Services, and Eurofins Clinical Trial Supplies are building a stronger connection to provide a seamless solutions-based approach to our client needs. Eurofins Clinical Trial Solutions provides seamless, end-to-end solutions to help clients progress through the drug development cycle through a single, experienced provider. Our integrated solutions deliver the most comprehensive range of state-of-the-art analytical technologies with an expansive geographic reach in order to support our clients’ specialized testing needs and stringent quality and safety requirements around the world.

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Assay AssemblyAssay Assembly is technique used in drug discovery to develop assays to test the cytotoxicity, genotoxicity, or other activities of a compound on a cell. Assay assembly requires chip assembly, a delivery system and a detection and analysis method. Beneficial features of assay kits or automated systems include high-throughput, high speed and sensitivity and low signal to noise ratio.Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. Find the best flow cytometers, cell counters and cell sorters in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.MultiplexingMultiplexing refers to the ability to measure multiple targets or analytes simultaneously in a single experiment. This technique is valuable for high-throughput screening, diagnostics, and complex assays, as it increases efficiency and data quality. Browse our peer-reviewed product directory to find the best multiplexing products, compare tools, check reviews, and get pricing directly from manufacturers.

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