Search results for " process characterization"

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 biopharmac…

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 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 more…

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…

Poster Mixing and Temperature Characterization of Single-Use Mixing Systems
Single-use mixing systems are widely used in biomanufacturing due to the many advantages that come with disposables, including reduced cross-contamination risk and shorter batch changeover time. Th…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Bioterminology: A Guide to the Biopharmaceutical Lexicon This lexicon was generated by the editors of BioPharm International magazine. Please feel free to email your suggestions for terms that s…

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 …

Article QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, assoc…

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