The latest issue of BioProcess International focuses on bioprocessing analytical methods including particle contaminant identification, host cell protein detection, cell culture process development, and articles on using QbD for monoclonal antibody processes, cost modeling for bioproduction, the role of Big Data in biopharmaceutical R&D, and the Bioprocess Insights Special Report.
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Contract Services Supplement
Key topics in this issue are capacity predictions, the challenge of preparing products for multiple regions, the influence of advanced and emerging therapies on service offerings, the incorporation of new platforms and analytical methods, and the continuing exploration of disposable technologies (and how they, among other tools, are advancing progress toward continuous operations).
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State-of-the-art analytics guide process development by providing companies with thorough understanding, effective removal, suitable control, and comparability assessment after process changes of host cell proteins (HCPs) in recombinant biotechnology products. An array of analytical techniques and approaches can be used to establish control strategies for host cell proteins. Techniques used for HCP characterization and comparability include two-dimensional (2D) gel electrophoresis with a range of stains, 2D immunoblotting, 2D high-performance liquid chromatography (HPLC), 2D difference gel electrophoresis (DIGE), and increasingly mass…