Search results for " therapeutic" in Articles / App Notes
Article
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…
Article
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 …
Article
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…
Article
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 …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…
Article
Managing Biomanufacturing Capacity Expectations
…macy benefit manager to reimburse a drug, a change in raw material availability, availability of new therapeutic alternatives, or new regulatory legislation.
In a Nature Reviews Drug Discovery st…
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A Bright Future for the Plasma Fractionation Industry
Some of the examples given by Perreault were in the area of recombinant plasma proteins, disruptive technologies, and especially improved diagnosis of patients and better access to therapeutics. Perre…