Search results for "bioburden"
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…
Article
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
Article
Process Chromatography: Continuous Optimization
…ncentrations of sodium hydroxide needed for cleaning and sanitization, which increases the risk for bioburden issues, according to Westman. “We believe that both binding capacities and chemical resis…
Poster
Impact of sporicidal agent on MabSelect SuRe™ protein A resin lifetime
Bacterial endospore contamination constitutes a challenge in bioproduction due to their resistance to high concentrations of NaOH, commonly used in sanitization procedures. Hence, there is an intere…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Design and Qualification of Single-Use Systems
bioburden, endotoxins, and particle contamination or generation.
• Packaging and shipment containers must be designed to effectively protect the SUT component or assembly during transport from the…
Article
Platform Approach Speeds Process Development
In a disposable process chain, changeover activities are reduced, which lowers the risks for bioburden and eliminates the risk for carry-over of residual product. The faster changeover is beneficial f…
Article
Fluid Handling in Biopharma Facilities
Kaap (Parker domnick hunter): Besides open-vessel mixing, most single-use applications for bioprocessing steps involve low bioburden fluids being transferred. There is a trend to move to closed system…
Article
Continuous Chromatography: Trends, Definitions and Approaches
… system, and making sure that the system can be cleaned during the operation removing any potential bioburden risks.
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