Search results for " biotherapeutic"
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
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Best Practices for Selecting a Top-Quality Cell Line
If the secretory system cannot handle the secretory throughput, the biotherapeutic proteins can become misfolded or have improper secondary modifications,” he explains.
This issue is particular…
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Preclinical Evaluation of Product Related Impurities and Variants
Despite their success, the adoption of biotherapeutics is marred by issues around affordability as well as risks associated to the challenges in assessment of their safety and efficacy arising from th…
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Labeling of Biosimilars
…earch-based drugs industry, has claimed that in addition to biosimilars, there are “non-comparable biotherapeutic products” on the world market, which have not undergone complete comparability exerci…
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CMOs Concerned With Cost of Single-Use Equipment
Figure 1: Selected “Most Important Reasons” for not increasing use of disposables, biotherapeutic developer vs. CMOs.
For biotherapeutic developers, the most crucial reasons restricting greater …
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CMOs Continue to Improve Overall Biomanufacturing Performance
Indeed, single-use implementation and integration is a much larger focus for CMOs than it is for biotherapeutic developers. And as the results in Figure 1 indicate, it’s easy to see why: nine out of 1…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…
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Updating Viral Clearance for New Biologic Modalities
However, demonstrating viral clearance is even more difficult with the newer biotherapeutic modalities being developed today such as viral vector-based gene therapies. Many of these new and evolving b…
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Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Download the free e-book on Better Biotherapeutic Characterization here.
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Continuous Processing for the Production of Biopharmaceuticals
The biotherapeutic industry is presently undergoing a similar transition (2).
The industry already has experience in terms of continuous upstream processing. Perfusion technology has been successf…