Search results for "Protein" in Articles / App Notes
Article
QbD and PAT in Upstream and Downstream Processing
Protein glycosylation, for example, is generally determined during cell culture and minimally altered in downstream unit operations (at least for uncharged glycosylation species). Using this definitio…
Article
PDA's Technical Report for Biotech Cleaning Validation
The report also considers the effect of degradation of the active on cleaning-validation practices and the widespread use of nonspecific methods, such as total organic carbon (TOC) and total protein, …
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Technology Innovations Improve Process Chromatography Performance
“In downstream processing, the ultimate goal for biopharma manufacturers is to improve recovery and reduce the cost per gram of protein produced. Currently, over 60% of the cost to produce a new biolo…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
SPR is a rapidly emerging tool for studying ligand binding interactions with membrane proteins, which are the major molecular targets for biopharmaceutical products (6). In SPR, one of the interactant…
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Managing Residual Impurities During Downstream Processing
Challener
Manufacture of protein and other biologic drug substances via cell culture or fermentation occurs with the natural, simultaneous production of other unwanted materials, particularly host-…
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Q&As with Industry Leaders
…obal Product Manager, Monoclonal Antibody Polishing, Cytiva
Top challenges in recombinant protein purification process development
Jeanne Linke Northrop, BioPharm International
…
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The Development and Application of a Monoclonal Antibody Purification Platform
Such increases could change the characteristics of the cell culture broth, leading to higher levels of product-related heterogeneous proteins (aggregates, degradation products, processing variants) an…
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Milestones and Moderate Progress in 2012 Drug Approvals
25, 2012, with the approval of Glybera (alipogene tiparvovec) by the European Commission for use in the treatment of lipoprotein lipase deficiency within the EU. Lipoprotein lipase (LPL) deficiency is…
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Top Tips for Successful Development of Antibody Chromatography Processes
We've seen this specific drug class continue to reshape medicine, right? It's so amazing what we've learned about these molecules, their potential, the different ways to leverage these proteins. I'm r…
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Optimizing your Cell Culture Process to Improve Productivity
It could also be used to analyze monoclonal antibody protein quality by examining the parameters, supplements, and feed timings, which may help increase the quality of the protein being produced in cu…