Search results for " monoclonality"
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
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Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
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Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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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
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Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
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The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
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What Drove Biopharma Development in 2014?
Process Development Forum (PDF) featured a myriad of topics at the forefront of biopharmaceutical development. But some issues stood out as garnering the most attention from readers in 2014. One of …
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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…