Search results for " cell-culture" in Articles / App Notes
Article
Selecting a Comprehensive Bioburden Reduction Plan
Filtration may be used for cell-culture media or buffers. Chromatographic steps, low pH, and chemical inactivation provide virus reduction during processing. Virus and sterile filtration prior to fina…
Article
Quality Systems Key to Lifecycle Drug Management
PACMPs may be appropriate for certain changes to biological products, such as adding a new cell-culture facility, and should be most useful for drugs developed using QbD principles, Robert commented. …
Article
Re-use of Protein A Resin: Fouling and Economics
These resins have been designed to keep pace with increasing bioreactor volumes and cell-culture expression levels and thereby prevent Protein A capture from becoming a bottleneck in the purification …
Article
Fermentation for the Future
Drivers of new technology development in microbial fermentation are similar to those for cell-culture processes and include reducing costs, increasing efficiency/productivity, and enhancing quality, s…
Article
Technologies and Practices Must Evolve to Meet Demand
Jan 01, 2015 By Rita Peters
Through Dec. 3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule …
Article
Improving PAT for Biologics
Implementing PAT for bioprocesses presents unique challenges given the greater complexity of cell-culture and fermentation processes, the variability of raw materials (particularly living organisms), …
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Challenges of Protein Aggregation During Purification
Barrett adds that it has been recently found by some biopharmaceutical manufacturers that the addition of copper at the cell-culture stage leads to a significant reduction in aggregation downstream, a…
Article
Single-Use and Continuous Processing Technologies Change Facility Design
With no waiting for cell growth and cell-culture bioreactors continuously operating, columns can be smaller than when they need to handle whole fermenter volumes at one time. Ultimately, the whole fac…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
To prepare feed media for cell lines A and B, the formulated powder was added into water for injection (WFI) or cell-culture-grade water at 37°C, followed by addition of Polysorbate 80 (PS80) or P188.…