Search results for " methods" in Articles / App Notes
Article
Improving Upstream Predictability
Traditional quality control (QC) methods will also become outdated as the industry moves to continuous processing. “We will need to replace current QC methods with in-line testing technologies, and th…
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Driving Improved Access to Biosimilars
The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12). According to reports on May 13 and May 21 in the Regulatory Affair…
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Monitoring and Control of Inline Dilution Processes
“Automated buffer preparation methods can lead to a more efficient use of existing resources, including labor and consumable savings, and smaller facility footprints. Eventually, by getting more out f…
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How To Interpret Protein Binding Capacity: Chromatography Resins
Different methods may have to be used, and often these methods are not stated directly. Explore what protein binding capacity is, how it can be measured and what exactly to look for on a manufacturer’…
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Interpreting Protein Binding Capacities for Chromatography Resins
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Comparing the protein-binding capacities of resins from different suppliers is not straightforward because different methods may have been used and these methods are n…
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Gain Efficiency in Process Development
The development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient informatio…
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NIST Spectroscopic Measurement Standards
Cole*is group leader bioassay methods, Kenneth.cole@nist.gov; Paul DeRose, Brian Lang, John Schiel, and Aaron Urbas are research chemists; Hua-Jun He and Erica V. Stein are research biologists; Evelyn…
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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…
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Transformative Medicines Challenge FDA and Manufacturers
The situation puts a premium on efforts by FDA and biopharma companies to identify efficiencies and improved methods for testing and producing cutting-edge medical technologies. It also highlights the…
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Fusion Proteins Pose Manufacturability Challenges
He does note, however, that for other downstream operations, wider options for polishing chromatography steps to remove aggregates and viral inactivation methods that don’t require low pH treatment ar…