Search results for "Protein A"
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Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
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Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
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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
Looking for a purification protocol to reach yield and target purity of your protein? Setting up a multistep purification might be the way forward for your lab.
With the right combination of dif…
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Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
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Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
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Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…