Search results for " monoclonal"
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
England (Taylor Wessing): Increasing patent litigation is being seen concerning biosimilar versions of biological products, most often monoclonal antibody treatments. The complexity and value of these…
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New Therapies Present Scaling Challenges
However, differences in manufacturing cycles for emerging therapies, compared with that of the traditional monoclonal antibody (mAb) therapeutic, calls for different strategies to increase production.…
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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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Design Considerations for a Commercial Cell and Gene Therapy Facility
Different from mAbs
Considering the differences between monoclonal antibody (mAb) production and cell/gene therapy production is also important when establishing a cell/gene therapy facility. Al…
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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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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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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …