Search results for " therapeutic"
Article
Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
Leronlimab is a novel CCR5 antagonist with the potential for multiple therapeutic indications. It has been and is currently being administered to COVID-19 patients at New York City area hospitals as p…
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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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N-Glycan Analysis of Biotherapeutic Proteins
Figure 1A represents some of the therapeutic effects of biantennary N-glycans of the Fc region of IgGs. Interaction of the Fc region of IgG with Fc-γ receptors (FcγR) influences immune effector functi…
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Implications of Cell Culture Conditions on Protein Glycosylation
These differences in glycosylation can have significant effects on the quality of the therapeutic protein produced, as can the choice of cell clone, the basal and feed media used, and the cell-culture…
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Host-Cell Protein Measurement and Control
HCPs are proteins produced or encoded by the host organisms used to produce recombinant therapeutic proteins (1). Recombinant therapeutic proteins are usually produced by genetically-modified prokaryo…
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Predicting Progress in Protein Aggregation
… particularly high-throughput methods, to enable the design and formulation of stable, protein-based therapeutics.
The importance of aggregation
Because aggregation can occur at any …
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Evolution of the Monoclonal Antibody Purification Platform
This 31st article in the “Elements of Biopharmaceutical Production” series focuses on evolution of the purification platform for manufacturing of mAb therapeutics.
Traditional Mon…
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A Closer Look at Affinity Ligands
Large-scale manufacturing of a therapeutic monoclonal antibody (mAb) starts with the expression of the antibody in mammalian cells, typically CHO [Chinese hamster ovary] cells, followed by a series of…
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Reimagining Affordable Biosimilars
Because the therapeutic dose and clinical indications are established by the reference product, Phase II trials are typically not required for biosimilars. A Phase III trial is a confirmatory study fo…
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Emerging Therapies Test Existing Bioanalytical Methods
It is important to understand the complex assays needed for these programs and work with partners that provide expertise to ultimately expedite these highly complex therapeutic classes.
Specialty …