Search results for " process" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
And for those sponsors who do embrace a more comprehensive, “enhanced approach” to development, a solid understanding of product quality attributes serves as the touchstone upon which process design a…
Article
Trends in Downstream Bioprocessing
Downstream processing (DSP) has seen significant challenges over the past few years. Improved upstream bioprocessing has created increasingly higher product titres and resulted in purification bottle …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
…, availability of humanized forms that can attenuate immunogenic responses, and robust manufacturing processes (3, 4). Poor stability of monoclonal antibodies outside their natural environment, howev…
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
One such factor is better process development, cited by 81.8% of CMO respondents as contributing to improved biomanufacturing performance, up from two-thirds of respondents in 2014.
This is …
Article
Continuous Chromatography: Trends, Definitions and Approaches
For the very low titer processes, or rather for the cases where the ratio of capacity-to-feed concentration is very high, even a 2-column system will be sufficient.
Can you comment on the import…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
48-64
The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …
Article
A Closer Look at Affinity Ligands
In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development, BioCina; Jan Bekker, PhD, director, Business Development, Commercial and Technical Operations…
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
5:10 - Top tips for implementing mechanistic modeling into process development work.
6:50 - Key benefits of in silico process development driven by mechanistic models.
Visit cytiva.com/m…
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,”…