Search results for "bioburden" in Articles / App Notes
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The primary factors that affect the risk of microbial proliferation during hold times are the growth-promoting properties of the in-process materials, initial bioburden level, and storage conditions. …
Article
Sterilization Trends for Single-Use Consumables
Some may be provided to a biomanufacturer without being irradiated or having been irradiated to minimize bioburden risk but without any claim of sterility. “It is therefore paramount that manufacturer…
Article
Digitalization: The Route to Biopharma 4.0
However, there are many attributes such as charge variant, aggregates, host-cell proteins, and bioburden that cannot be measured online at present and require sampling and offline analysis (19). Creat…
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
Sanitization Opportunities for Protein A Resins
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Bacterial endospores present a challenge in bioproduction due to their resistance to common sanitization procedures using high concentrations of NaOH. Several protein-b…
Article
Technology Innovations Improve Process Chromatography Performance
“The current process technologies, such as functionally closed single-use manifolds for [chromatography] skids, pre-packed columns, and robust sensor components, enable long-term processing in a biobu…
Article
Moving PAT from Concept to Reality
Numerous at-line analyses evaluate host cell proteins (HCPs), DNA, viable cell density, bioburden, aggregates, product concentration, and particulates.
One of the greatest difficulties with many c…
Article
Cleaning Protein A Resins with 1 M NaOH
With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material i…
Article
Chromatography Scale-Up: Don’t Get Tied Down by Bed Height
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When scaling, you can make better use of existing chromatography columns while avoiding overcapacity.
Keeping a constant residence time is a well-est…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
Another challenge is maintaining sanitary conditions in a continuous process; the control of bioburden, while basic, is fundamental to success, said Galliher.
Implementing automation technology ca…