Search results for "antibodies" in Articles / App Notes
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Unlike other biological drug products such as therapeutic proteins, monoclonal antibodies, or vaccines, drugs based on living cells are by nature uniquely vulnerable to supply chain complications and …
Article
A Continuous Confidence Boost
Continuous processing of monoclonal antibodies (mAb) could offer a number of advantages, but regulatory uncertainty and upfront investment remain sticking points.
In this case study, Shanghai Henli…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Driving Improved Access to Biosimilars
Thomas Linneman, head of regulation CMC customer solutions at Solvias, divides them into monoclonal antibodies, hormones, and Fc fusion proteins and cytokines (4). Although approved, these drugs are n…
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2019 HTPD Conference Abstract Submissions Are Coming Up: What Happened Last Time?
HTPD 2019 will cover process development spanning upstream through downstream processing for both monoclonal antibodies (mAbs), Ab-like molecules as well as novel biomolecules. Sessions will …
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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
These products are not well-characterized molecules like monoclonal antibodies, but a complex of various proteins, DNA/RNA, and in some cases lipid membranes. “This complexity makes it hard to identif…
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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…