Search results for " cleaning" in Articles / App Notes
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane
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Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…
Article
Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…
Article
Efficient Sodium Hydroxide Sanitization with a Novel Procedure of AxiChrom™ Columns Packed with Chromatography Resin
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Sodium hydroxide (NaOH) cleaning-in-place is the widely accepted method of sanitization employed by biopharmaceutical manufacturers to avoid the excessive costs and delays of a…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
…he other hand, protein-based affinity resins are often more expensive and more sensitive to standard cleaning protocols, Ihre cautions.
“In general, I would say that if the target molecule is eit…
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Next Generation Process Chromatography
As multiple cycles are usually run and setup, cleaning and winddown times contribute a decent proportion of this duration.
Fibro is a new chromatography technology platform that promises purificat…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Accurately detecting impurities when performing cleaning verification is also difficult because the levels are very low, says Chandrasekaran. “The method must be sufficiently sensitive or cross-contam…
Article
Flexible Facilities for Viral Vector Manufacturing
Murphy says the primary benefit for single-use systems is eliminating the need to perform cleaning validation on reused product contact equipment.
References
1. C. Challener, Pharm.Tech. 43 (9…
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …