Search results for " Mabs"
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
As of February 2017, FDA lists 68 approved mAbs, and approvals have been increasing each year since the late 1990s (3). mAbs are comprised of several domains that contribute to their function. The Fab…
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Ligand-Binding Assays and the Determination of Biosimilarity
In addition, for mAbs, ligand-binding assays do provide a valuable assessment of biosimilarity and should be included, orthogonally, with cell-based functionality assessments.
Just one part of the…
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Single-Domain Antibodies for Brain Targeting
Conclusion
After a decade of intensive engineering followed by preclinical and clinical testing, antibody fragments joined mAbs as powerful therapeutic agents particularly for targeting cancer, in…
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Digitalization: The Route to Biopharma 4.0
AI-ML Applications In Bioprocessing: ML as an Enabler of Real Time Quality Prediction in Continuous Manufacturing of Mabs. Computers & Chemical Engineering 2022, 164,107896. DOI: 10.1016/j.compchemeng…
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As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
For traditional mAbs, protein A chromatography is used to capture antibodies. Depending on the structure of the target antibody and the impurity profile, other affinities, like protein L or variants o…
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Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
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Updating Viral Clearance for New Biologic Modalities
Guidance is needed
Compounding all these challenges is the fact that published regulatory guidances have been based on traditional biologics, such as mAbs and related Protein A binders, says Berri…
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Process Development: 2020 Reflections and 2021 Possibilities
On the note of mAbs, another area of interest in 2020 was strategies to improve the mAb manufacturing process and streamline overall bioprocessing operations. mAb manufacturing productivity can be gre…
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Reimagining Affordable Biosimilars
A typical study for complex biologics, such as mAbs, includes the following components: assessment of acute toxicity (two-weeks to one month) via single- and multi-dose studies, including evaluation o…
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Flexible Facilities for Viral Vector Manufacturing
“Compared to mAbs, viral vectors are much larger, more complex molecules that are highly susceptible to various factors in their manufacturing environment, such as mechanical shear, pH, and temperatur…