Search results for " monoclonal"
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
For example, the time needed to achieve enzymatic deglycosylation of monoclonal antibodies has been reduced by nearly two orders of magnitude. Certain products (e.g., Rapid PNGase F, New England Biola…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Cytiva stated in a recent press release that a new standard for monoclonal antibody purification is being set. Can you elaborate on that?
At Cytiva, we felt that with our knowledge and experience…
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Witnessing Major Growth in Next-Generation Antibodies
Challener
Next-generation antibodies are designed to be more specific and are often more potent than traditional monoclonal antibodies (mAbs). As a result, their commercial potential is significan…
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Analysis of Glycosylation in Biosimilars
The structures of protein drugs such as monoclonal antibodies are made more complex by post-translational modifications. The most notable of these is glycosylation, where carbohydrate residues are att…
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Platform Approach Speeds Process Development
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
Commercial production of complex biopharmaceuticals such as recombinant monoclonal an…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
This early screening approach has identified cryptic aberrant splice sites in multiple therapeutic candidates including monoclonal antibodies, bispecific antibodies, and fusion proteins, therefore pre…
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Host-Cell Protein Measurement and Control
In a typical recovery process for a therapeutic monoclonal antibody, the highest concentration of HCP is detected in the harvested cell culture fluid (HCCF), and then cleared through additional downst…
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The Bullish Outlook for Biosimilars
In 2013, the EU’s decision to formally approve both Remsima (infliximab) and Inflectra (infliximab)--the world’s first monoclonal antibody (mAb) biosimilars by Celltrion and Hospira, respectively--rep…
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What Drove Biopharma Development in 2014?
To that end, PDF articles and posters related to monoclonal antibodies (mAb) were well received by website visitors. In fact, the monoclonal antibody market represents the fastest growing segment with…
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Address the complexity of protein characterization
Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant clinical success and have been used to provide effective treatment for a range of diseases. Durin…