Search results for " Mabs"
Article
Scaling a mAb production process to Xcellerex bioreactors
Moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
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Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAbs at Large Scale
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As process intensification is adopted into large-scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quic…
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Strategies and Emerging Technologies for mAb Capture
20 May 17 CEST | 11 EDT
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAb at Large Scale
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As process intensification is adopted into large-scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quick…
Article
Connected, Automated Downstream Process for mAb Screening and Evaluation
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A pre-clinical lab is often faced with the need to constantly evaluate possible ways of increasing capacity and throughput. This study was done to show both proof of p…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Development of clear, regulatory approval pathways for biosimilars in emerging markets is creating large, additional opportunities for biosimilar mAbs. Education of physicians, pharmacists, and patien…
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Evolution of the Monoclonal Antibody Purification Platform
What is unique about mAbs from a processing perspective is the applicability of developing a common process and analytical platform (2, 3). Some process development related attributes with respect to …
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address these challeng…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
…pping are routinely used to assess and compare the protein backbone of the light and heavy chains of mAbs (10, 11) and can be valuable tools in determining product CQAs. Intact molecular weight analy…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
REGULATORY EXPECTATIONS FOR THE ANALYSIS OF MABS
Several guidance documents have been issued by regulatory agencies recommending approaches for protein characterization.3,4 Although guidance docum…