Search results for " methods"
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Challenges in Analytical Method Development and Validation
The development and validation of analytical methods is crucial in drug development. While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technolo…
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Using Quality by Design to Develop Robust Chromatographic Methods
In 2010, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Subteam on Analytical Methods introduced the concept of applying QbD principles to analytical methods (5) where t…
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Design of Experiments for Analytical Method Development and Validation
Recently, more attention has been placed on applying DOE to analytical methods. DOE for analytical methods has three major applications: method development for new methods or those that need improveme…
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Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
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Tackling Analytical Method Development for ADCs
Both small and large
As for any drug, analytical methods for the characterization of ADCs must be developed, and separate quality control (QC) tests must be established for lot release of the fina…
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Emerging Therapies Test Existing Bioanalytical Methods
Cell-therapy products that meet the definition of “biologic product” require complex analytical strategies and unconventional bioanalytical methods to determine distribution and persistence of the pro…
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Simplify chromatography method creation
Efficient method creation is often about finding useful tips on how to develop methods easy to maintain, reuse, and share.
In this blog post, you can read about tips and tricks to simplify method …
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Methods Accelerate Biosimilar Analysis
Unfortunately, these methods are low resolution and fail to provide structural details that distinguish among subtle differences in higher-order structures.
It is possible to use multidimension…
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Master the basics of UNICORN™ method editing with a free online course
This free interactive course explains how to create and edit methods in
UNICORN™ software for ÄKTA™ chromatography systems.
Review the basics and learn how to use predefined phases…
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Generate an Automated Purification Protocol in Three Steps Using Predefined Methods