Search results for "bioburden" in Articles / App Notes
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…
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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Article
Re-use of Protein A Resin: Fouling and Economics
These include lysophosphatidic acid (LPA) analysis and HETP measurement, as well as monitoring of bioburden, endotoxin, host cell proteins, and media components in the pool over resin lifetime.
Fa…
Article
Tackling Analytical Method Development for ADCs
Testing for safety and quality attributes (bioburden, endotoxin, pH, osmolality, excipients, and appearance) are either verified using compendial-based platform methods or developed per product.
A…