Search results for " bioburden"
Article
Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez
There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…
Article
Bioburden Control in the Biopharmaceutical Industry
Good Practices in the Biopharmaceutical Industry
Because bio/pharmaceutical products are generally intended for ill populations, bioburden control throughout the whole manufacturing plant should b…
Article
Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
Article
Sources of Bioburden You Might Have Missed
The open handling introduces many potential bioburden entry points.
In this new blog-article, potential bioburden sources in bioprocessing are discussed and ways to address the risks.
Read m…
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How to Address Bioburden Challenges: Insights and Tips
Learn more about insights and tips to address bioburden challenges here.
Article
The Extreme Costs of a Bioburden Incident
Read the bioburden article series.
Poster
Collaborating to address the bioburden challenge
At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies …
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Article
Prepare for an FDA Bioburden Inspection
Even with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help…
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
…chromatography resins, enabling new possibilities in cleaning and sanitization efficiency to address bioburden risks and process economy. The binding capacity has been increased more than 40% compare…