Search results for " activity" in Articles / App Notes
Article
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…
Article
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…
Article
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 …
Article
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 …
Article
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…
Article
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…
Article
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…
Article
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%)…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…