Search results for " method" 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Traditional quality control (QC) methods will also become outdated as the industry moves to continuous processing.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…
Article
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The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12).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’…
Article
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…
Article
Gain Efficiency in Process Development
Features such as easy method development, reliable unattended operation, and quick process scaling can help save time and optimize your equipment utilization.
In this article, learn how represent…
Article
NIST Spectroscopic Measurement Standards
Stein, Brian Lang, John Schiel, Aaron Urbas, Evelyn Solis, Steve Choquette
Abstract
Ultraviolet (UV) absorbance measurements provide a rapid and reliable method to determine protein…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed. In a microbial challenge test, parts were exposed to a bacterial strain recommended by the United Stat…
Article
Transformative Medicines Challenge FDA and Manufacturers
FDA approved Spinraza with a number of post-approval study and quality assessment commitments, including programs to re-evaluate drug substance method validation data and acceptance criteria, to re-ex…
Article
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…