Search results for "contamination"

Article Perfusion in the 21st Century
Such manufacturing sites generally have smaller reactors and are faced with the challenge of preventing cross-contamination. Regulatory agency interest in the greater process control and product consi…

Article Analysis of Glycosylation in Biosimilars
…ephadex 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 more…

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
With single-use systems, “The changeover to another product can be swift, and potential cross-contamination can be avoided, since the product contact layers are disposable,” says Jornitz. Plus, if “ca…

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
Modular facilities also boast the added benefits of flexibility, as well as the highest security from a cross-contamination and regulatory perspective. Regulatory Requirements BioPharm: Are th…

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…

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