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Cell line development: The linchpin in successful biotherapeutic development

Abzena
22 Jan 2024

In this whitepaper from Abzena, the focus is on the expanding antibody-based biologics market, which is expected to grow rapidly, targeting various therapeutic areas. To efficiently deliver these biologics, a robust cell line development (CLD) strategy is suggested. CLD, as the foundation of drug manufacturing, requires a proactive approach to identify potential risks and challenges, ensuring timely development. A strong CLD strategy is highlighted for its ability to accelerate timelines by enabling parallel development activities and enhancing lead candidate selection through the generation of fast stable pools. The whitepaper emphasizes the importance of considering various factors in building a reliable CLD strategy, including access to experts, understanding downstream implications, and staying informed about applicable regulations.

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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.ProteomicsProteomics is the systemic bioinformatics study of proteins and amino acids, including their structure, size, function and identification. Tools used in proteomics include chromatography, blotting and gels, protein arrays, mass spectrometry and ELISA and associated analysis software. Analyzers and proteomic systems should be sensitive, high resolution, fast and may be automated for high-throughput.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.Cell AnalysisThe analysis of cells allows researchers to understand the factors which contribute to cell health and function. These influencing processes can then be predicted and altered, leading to the development of medication and disease treatments.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.Cell Line Development

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Cell line development: The linchpin in successful biotherapeutic development