Search results for " process characterization" in Articles / App Notes

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time. ABSTRACT Monoclonal antibodies represent a significant portion of sales in the biopharma…

Article Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …

Article On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
This webinar illustrates a cation exchange chromatography process development workflow to assess the effect of ligand density variability on product quality and process performance using a Process Cha…

Article Introducing Process Characterization Kit: New Tools for Gaining Deeper Chromatography Process Understanding
Study the potential impact of resin ligand density on process outcome with Process Characterization Kits. The kits provide critical insights on resin variation within the ligand density specificatio…

Article Studying Resin Variability Using a Process Characterization Kit
Learn how Process Characterization Kits can be used to assess the potential impact of resin ligand density variability on product quality and process performance. Click here to read mor…

Article Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Surface plasmon resonance (SPR) has become a go-to tool for biotherapeutic characterization, and most approved antibody therapeutics have passed through a Biacore SPR system. Stay up-to-date wit…

Article Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
This webinar presents the utility of Biacore™ systems at all stages of the process, from selection of first candidates to clinical lead, as well as how to shorten and streamline the time to results …

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Overall, the design space developed from process characterization study models represents a level of process understanding. Like all models, however, the design space is only as good as the data that …

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