Search results for "Protein"
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Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
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Methods Accelerate Biosimilar Analysis
Intact mass analysis by HR-MS can provide an abundance of information about the integrity of the molecule and glycoforms comprising the protein product or the presence of oxidation, truncation, or oth…
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Addressing the Complex Nature of Downstream Processing with QbD
“For instance, protein A or affinity resins in general, as well as flow through steps, display these properties since these steps in most cases build on a fundamental understanding of the physiochemic…
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Ion Exchange Chromatography: Introducing New Capto™ HiRes Columns
• Designed for the preparation of highly pure proteins and for protein analysis, such as analysis of mAb charge variants.
• Replacing the well-established Mono Q™ and Mono S™ columns—with transiti…
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Combining Purification Techniques in a Multistep Approach
With the right combination of different purification techniques, resins used, and how your methods are set up for a multistep approach, your protein purification will be successful in terms of either …
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Witnessing Major Growth in Next-Generation Antibodies
The global market for next-generation antibodies, including antibody drug conjugates (ADCs), engineered antibodies, bispecific antibodies, antibody fragments, antibody-like proteins and biosimilar ant…
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Perfusion in the 21st Century
Perfusion was first introduced in the 1980s to enable the production of sensitive proteins that degraded when left in bioreactors under batch and fed-batch conditions. Around the same time, continuous…
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Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
The technique offers high selectivity, hence high resolution, and usually high capacity for the protein(s) of interest. Purification can be in the order of several thousand-fold and recoveries of acti…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
…l-culture media are essential raw materials that are required for the manufacture of biotherapeutic proteins. Cell-culture media are composed of multiple components, and therefore, it is difficult to…
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Tools for Continuous Bioprocessing Development
The repeated deformation of the endoplasmic reticulum can be detrimental to protein glycosylation. Bioreactors with different chamber volumes will have different circulation times, and hence, some ben…