Search results for "contamination" in Articles / App Notes
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…
Article
2014 Manufacturing Trends and Outlook
Nearly 70% cited reduced contamination as an advantage. Time savings, ease of use, and flexibility for multiproduct manufacturing were identified as advantages by more that half of the respondents (Fi…
Article
Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
…pdate/improve outdated manufacturing processes and methods that pose quality risks, such as product contamination, excessive process variability, and lack of consistent product quality. Regulatory au…