Search results for " impurity" in Articles / App Notes
Article
Unifying Continuous Biomanufacturing Operations
“For example, within one run of a reactor, four different cell concentrations (40, 60, 80, and 100e6/mL) could be held for a week each, and the downstream group may evaluate the product quality and im…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar
Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Single-use technologies in downstream process intensification
In bioprocessing, thorough cleaning is critical in order to take full benefit of the resin by removing impurities. When using conventional chromatography solutions, cleaning and cleaning validation …
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
Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Process Development Forum speaks with Günter Jagschies, Cytiva, who is sitting on the organizing committee for the Recovery of Biological Products XVII Conference, which will take place June 19-24, …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
…to initial CQAs are maintained; and to secure that the process itself is well controlled and has low impurity levels. Formulations ensure that the final product has proper stability, administration p…
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…