Search results for " contamination"
Article
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
Article
Analysis of Glycosylation in Biosimilars
…Sephadex beads, for example, in the purification process, and high mannose levels may indicate yeast contamination.
With this information in hand, the next steps are to study the glycoprotein mor…
Article
Antibody Production in Microbial Hosts
In addition, viral contamination of a therapeutic protein preparation can be altogether avoided with cultivation in microbial system. While mammalian systems have been predominantly used for the expre…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
Modular Manufacturing Platforms for Biologics
Although the goal of a cleanliness classification through a Federal Standard 209 is to prevent contamination, as PortaFab points out on its website, “the presence of viable particles (living organisms…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Obviously, prevention of bioreactor contamination is of paramount importance if the reactor is operated in perfusion mode and is connected to a continuous chromatography system, but this can be realiz…
Article
Vaccine Development and Production Challenges Manufacturers
Sanofi Pasteur had problems growing one of the four target flu strains, and GSK experienced contamination problems at its manufacturing facility in Quebec. The resulting vaccine, moreover, turned out …
Article
Securing the Single-Use Supply Chain
Although disposable systems do provide numerous advantages, such as reduced contamination risks, shorter set-up times, and lower capital costs, biopharmaceutical manufacturers do not have that same le…
Article
Challenges and Trends in Biopharma Facility Design
Companies taking advantage of these designs must remain focused on creating and implementing proper risk-management strategies to mitigate (and eliminate) potential product contamination, whether from…
Article
Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
It would seem that raw materials used in bioprocessing operations are a relatively straig…