Search results for " bioburden" in Articles / App Notes
Article
Securing the Single-Use Supply Chain
As an example, Rodriguez points to bioburden levels, which can be tested on every single lot or using a statistical approach. Both methods may be acceptable depending on the end-user’s specifications.…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
“The level of bioburden reduction and elimination that single-use technology provides is another huge motivator for its adoption in downstream processing,” he says.
About the Author
Cynthia A.…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
QbD and PAT in Upstream and Downstream Processing
…uality attributes for a cell-culture manufacturing process are limited to the adventitious agent and bioburden testing of the cell-culture harvest material. This also holds for biosimilar products.
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Article
PDA's Technical Report for Biotech Cleaning Validation
Limits for cleaning validation generally contain a measure related to the active protein or other major component of interest, a measure related to the cleaning agent, a measure related to bioburden l…