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
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…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…