Search results for "fermentation"
Article
Moving PAT from Concept to Reality
“This focus is in large part due to the fact that initial protein quality and effectiveness are established during cell culture or fermentation. Changes in the bioreactor conditions during protein pro…
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Second, scalable fermentation and downstream processing procedures were developed for each enzyme. These processes avoided the direct use of animal-derived components. Additionally, multiple productio…
Article
Understanding Validation and Technical Transfer, Part 3
Cell lines, fermentation processes, and bioreactions must be fully defined and described. This information serves as the foundation for producing material for clinical studies, initial regulatory fili…
Article
Preclinical Evaluation of Product Related Impurities and Variants
The level of these species, however, is usually controllable through fermentation and purification steps. There is no consensus among the regulatory agencies on the maximum allowable limit for these s…
Article
Single-Use Workflow for Recovery of a Domain Antibody from E. coli Culture Feed in an Automated Manner
coli was recovered from fermentation broth. The dAb-containing sample was clarified (2.5-times concentration) and further washed with three wash volumes, with a recovery of approximately 90% of produc…
Article
Process Chromatography: Continuous Optimization
Challener
Cell-culture and fermentation are high-yielding processes that effectively produce complex biologic molecules with desirable bioactivities. Even so, there are many impurities presen…
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The New World of Biopharmaceutical Manufacturing
Galliher (Cytiva): In the past five years, new advances include an increase in closed systems and in larger-scale, higher-throughput, high-duty applications, such as microbial fermentation and centrif…
Article
Managing Residual Impurities During Downstream Processing
Challener
Manufacture of protein and other biologic drug substances via cell culture or fermentation occurs with the natural, simultaneous production of other unwanted materials, particularly host-…
Article
Reconciling Sensor Communication Gaps
Historically, cell culture and fermentation persist longest among unit operations. Expression is “where the action is—where throughput and volumetric productivity exert the greatest influence on cost …