Search results for "Mab"
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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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Impact of Media Components on CQAs of Monoclonal Antibodies
Of these, mAbs comprise large, multi-domain proteins that require complex machinery for proper protein folding, assembly, and post-translation modifications. These modifications can profoundly affect …
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Antibody Production in Microbial Hosts
Rathore, Jyoti Batra
The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs) and related products that are capable of treating…
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Comparing Protein A Resins for Monoclonal Antibody Purification
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic and research uses, antibody titers in mammalian cell culture have increased dramatically over the past 20 years. …
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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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N-Glycan Analysis of Biotherapeutic Proteins
More than half of all biotherapeutics are glycosylated (2), including monoclonal antibodies (mAbs), Fc-fusion proteins, clotting factors, and cytokines such as erythropoietin. Of these, mAbs represent…
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Preclinical Evaluation of Product Related Impurities and Variants
Two case studies—one involving a microbial therapeutic product (granulocyte colony stimulating factor)—and other—a mammalian therapeutic monoclonal antibody (bevacizumab) have been used to illustrate …
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Process Chromatography: Continuous Optimization
Monoclonal antibodies (mAbs), which today account for approximately 50% of the total revenues of all biopharmaceuticals according to David Westman, global product marketing manager for Cytiva, are typ…
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QbD and PAT in Upstream and Downstream Processing
Some of these CQAs, such as glycoxylation pattern for monoclonal antibody (mAb) products, are primarily impacted by the upstream process and are particularly important to monitor during process develo…
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Advances in Engineering of Protein-Based APIs
Today, monoclonal antibodies (mAbs) have become one of the predominant forms of protein-based biopharmaceuticals, with humanization and fully human monoclonals contributing to their increasing success…