Search results for " process"
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
“These large-volume-liquid BPCs are used as the primary source of sterile process liquids or as a second source/back-up supply to reduce demand on the customer’s in-house capabilities and capacities,”…
Article
Challenges in Cell Harvesting Prompt Enhancements
Among the innovations are continuous processes/techniques that can mitigate the stress of high cell densities.
Centrifugation challenges
The centrifugation step uses the density difference bet…
Article
Impurity Testing of Biologic Drug Products
…t changes in efficacy, but understanding of the phenomena has led to improved, metal-free production processes.”
In general, impurities come from two major sources, observes Bérangère Ti…
Article
Modeling Bioreactor Performance
Challener
Bioreactor design, including the geometry of the tank and impeller and the locations of inlets, has a direct impact on the performance of cell-culture and fermentation processes. Modelin…
Article
Implementing QbD in Sterile Manufacturing
Critical quality attributes
BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing?
…
Article
Cell-Culture Advances Test Bioreactor Performance Models
The process of modeling has, in fact, advanced due to the increased capability to aggregate various sources of data (sensor measurements, batch record entries, product quality measurements, maintenanc…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors were able to show that a single resin can be converted to films that lead to substantially different amounts of leached degradation products, depending on how the resin is processed.
T…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Can you talk to us about the state of continuous processing in biotechnology?
A: Yes, the event is the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 20-21, 2014…
Article
Elucidating Biosimilars Characterization
…nch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved.
BioPharm International spoke with Jonathan Bones, principal investigator at …
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
During cell culture, even subtle variations in nutrient availability, dissolved oxygen, temperature, ammonia, and pH may impact the intracellular process of glycosylation (1,3) and yield product that …