Search results for "antibody"
Article
Intensified Chromatography Strategies
The blockbuster drug era is over and drug manufacturers are now striving for a more diversified portfolio by targeting a greater number of monoclonal antibody (mAb) products at lower production volu…
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Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
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Process analytical technology (P…
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Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
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In process development, it is desirable to test process parameters in small scale and later scale up the process into larger production scale. A theoretical scale-up study was per…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
In a study (4) that used modeling software to evaluate commercial monoclonal antibody (mAb) production, it was shown that the unit operation cost was 19% to 33% less for a membrane process used on 100…
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An Analytical Approach to Biosimilar Drug Development
For immunogenicity assays, the current industry practice is also to use a single assay, with the biosimilar as a capture reagent (and as the conf irmatory drug) when assessing antidrug antibody (ADA) …
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Why, Why, Why…ELISA? A Look at the Benchmark HCP Assay
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Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytica…
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Nurturing Knowledge from Disparate Data Streams
Anderson points to antibody-drug conjugates (ADCs) as an example. “ADCs comprise an antibody, a small-molecule cytotoxic payload, and a linker of some kind, which can be an oligomer or other small to …
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News: Cytiva Adds ELISA Kit to End-to-End HCP Monitoring Capabilities
Cytiva is pleased to announce the new Amersham HCPQuant CHO kit, a generic for detecting host cell protein impurities in drug samples produced in CHO cell lines.
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Numerous readers also explored semi-continuous processing, specifically an application note about how various unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected a…