Search results for " activity"
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…
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N-Glycan Analysis of Biotherapeutic Proteins
Glycosylation affects a variety of protein biological functions including folding, stability, and activity. These varied functions are enabled by the structural diversity of glycans, which stem from m…
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Being Thorough When Transferring Technology
This is why many organizations will send a representative(s) from the sending site to the receiving site well before the main thrust of activity.
One particular area that needs special attention i…
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Downstream Processing for Cell-Based Therapies
Much of the research and development activity in the sector has addressed the upstream challenges with particular emphasis on large-scale cell expansion; however, equally important is the development …
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Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
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Generating a Fully Processed Antibody
Also recently, the FGE enzyme was shown to require copper (II) for full activity (6, 7), so supplementation of copper (II) sulfate to the media optimizes amino acid conversion.
Cell-line engineeri…
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Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
A unique characteristic of adherent cells is their dependence on an anchorage surface on which to attach to exert their normal metabolic activity and proliferate. While cell attachment may prove advan…
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Antibody Production in Microbial Hosts
affinity to FcγRIIa than clinical grade drug and displayed enhanced antibody-dependent cellular phagocytoxic activity (42). This work deserves a special mention as FcγRIIa and FcγRIIb have high sequen…
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CMOs Continue to Improve Overall Biomanufacturing Performance
This is also a growing area of opportunity for CMOs, with validation services a more popular outsourcing activity than process development. In the 2015 survey, for example, almost three-quarters (73%)…