Search results for " comparability" 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
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Analytic technology is crucial
Because the emphasis in biosimilar manufacturing is on comparability and biosimilarity, analytic technology takes on an even greater importance in process developmen…
Article
Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
Increasing product titers in upstream cell culture processes pose challenges to downstream purification processes. For efficient operations, downstream purification needs to be able to handle high p…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Instead, they want to rely on comparability studies, noted Hillel Cohen, Sandoz executive director for scientific affairs. And after 10 or 20 years, he noted, a reference product may not be available …
Article
Validation of the production of influenza virus in ReadyToProcess WAVE™ 25 bioreactor system
This application note describes the validation of the single-use ReadyToProcess WAVE 25 rocking bioreactor system in production of influenza virus from Vero cells in microcarrier-based cultures. A 2…
Article
Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…
Article
Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology.
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biop…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
Biosimilars: Making the Switch Comes with Challenges
A major doubt is frequently their degree of comparability with the original biologics. Yet both regulators and producers believe that more could be done to eliminate uncertainties about biosimilars by…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
This approach will require additional effort to demonstrate comparability between the early-phase and commercial product, which potentially creates a risk of the need for additional clinical trials. A…