Search results for " specification" in Articles / App Notes
Article
Asked and Answered: Your Questions on Ion-Exchange Chromatography
On May 17, 2017, Marianne Carlsson presented the webinar, “Tips for Successful Ion Exchange Chromatography.” After the webinar, Marianne and a panel of R&D scientists participated in a live questio…
Article
N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
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From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
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Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
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Protein Purification Troubleshooting Guide
Practical advice to significantly impact your chromatography workflow
Put this poster on your lab wall to quickly identify and resolve protein purification problems when and where they happen. I…
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Managing Risk in Raw Material Sourcing
“It is important to ensure that any changes that might affect the products that customers buy or make, including changes to manufacturing processes, raw materials, product specifications, product tran…
Article
Automating Processes in Upstream Processing
By Susan Haigney
BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies, about automating processes in upstream processing.
BioP…
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Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …