Search results for " impurities" in Articles / App Notes
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Being Thorough When Transferring Technology
For small molecules, analytical testing can verify the exact structure of the molecule and impurities, whereas this is not possible for proteins due to post-translational modifications (glycosylation,…
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
Lynch stresses, however, that although capacity is an important feature, the capability of a resin to separate the molecule of interest from the other contaminants and impurities is the most important…
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
…r operational performance criteria, as well as potential chemical interactions and equipment-derived impurities or particulate contaminants that may be introduced into applicable processes and potent…
Article
Biosimilars: Making the Switch Comes with Challenges
…al stages, for example by implementing the latest analytics and other imaging technologies to detect impurities and unacceptable differences in structures and functionalities.
The EU was the firs…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Smart Bioprocessing has been chosen as the theme to emphasize the importance of understanding and controlling the origin of impurities, the impact of the production sources considered for the process,…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
ICH, Q3C (R5) Impurities: Guideline for Residual Solvents (ICH, Feb. 4, 2011).
10. M. C. Killilea, “Cleaning Validation: Viracept, 2007” IVT Network (Dec 3, 2012).
Editors’ Note: This articl…