Search results for "purification" in Articles / App Notes
Article
Single-Use Chromatography: Adapting to Manufacturing Scale
…cusses strategies for meeting the ever-increasing upstream titers and volumes to prevent downstream purification from becoming a bottleneck.
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Article
Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments, for example, Fab fragments. Various cleaning strategies and …
Article
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
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Process Development: What May Lie Ahead in 2018?
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Avoiding Investigational Failures and Discrepancies
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High Throughput Protein Purification at a Glance
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Top Trends in Biopharmaceutical Manufacturing, 2017
Article
Platform Technologies Improve Protein Expression
…smid design, cultivation medium, growth conditions, equipment, scalability, stability, and matching purification capability, to name but a few. Primary drivers to the development of a new therapeutic…
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Witnessing Major Growth in Next-Generation Antibodies
The synthesis of these molecules can be complex and involve extensive purification to obtain the desired structure.
“The further removed these molecules are from conventional antibody structures, …
Article
Critical Quality Attributes Challenge Biologics Development
BioPharm: How are CQAs in biologics defined?
Das (BMS): For recombinantly produced biologics, special attention is paid to the cell culture and purification process parameters as well as storage c…
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Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
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HTPD: Optimizing a mAb Chromatography Polishing Step
Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control of man…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Downstream processing goals include multiple stages of purification and concentration. Disposable, single-use filtration is an alternative to outdated centrifugation methods that are difficult to scal…