Search results for " biotherapeutic"
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Are You in Control of the Quality of Your mAbs?
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Modeling the Degradation of mAb Therapeutics
This article in the Elements of Biopharmaceutical Production discusses the kinetics of these degradation pathways as well as the insights they reveal that can help developers ensure the stability of b…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
One promising biotherapeutics category that may hold the key for achieving this goal is exosomes. These nano-scale membrane sacs are mediators of intercellular communication and can be exploited as ca…
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Platform Technologies Improve Protein Expression
“The goal beyond making some of these new entities viable is achieving a significant reduction in COGM, thus increasing the affordability of biotherapeutics and improving overall healthcare economics,…
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Impact of Media Components on CQAs of Monoclonal Antibodies
Major mammalian expression systems for the production of biotherapeutics include NS0 cells, baby hamster kidney (BHK) cells, hybridoma cells, PER.C6 cells, human embryonic kidney (HEK) cells, and Chin…
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Biacore Concentration and Ligand-Binding Analyses
During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, …
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Biomanufacturing Outsourcing Globalization Continues
As part of the survey, biotherapeutic developers are asked to estimate the percentage of operations at their facilities likely to be outsourced internationally in the next five years. A solid majority…
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Ligand-Binding Assays and the Determination of Biosimilarity
The importance of binding activity
Most biotherapeutics rely on specific binding activities to achieve a clinical effect. Therefore, matching the binding activities of a biosimilar candidate to th…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
Of particular interest to drug discovery is the application of siRNA as a biotherapeutic agent (1–5). To evaluate the suitability and effectiveness of siRNA as a biotherapeutic product, it is of inter…
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Digitalization: The Route to Biopharma 4.0
With the large number of CQAs that are associated with biotherapeutic products, their monitoring across the various process steps can be a challenging task. Digital solutions have emerged as efficient…