Search results for " method" in Articles / App Notes

Article 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…

Article 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…

Article 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…

Article 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…

Article Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…

Article Emerging Therapies Test Existing Bioanalytical Methods
Challenges remain for development of these therapies, particularly in the bioanalytical method approach required. Questions include the following: · How much of a dosed gene therapy is present in …

Article Simplify chromatography method creation
To save time and effort, method creation can be simplified and you can get to the point where you can start the run quicker. Efficient method creation is often about finding useful tips on how to deve…

Article Methods Accelerate Biosimilar Analysis
As the foundation in the development of biosimilars is the analytical strategy, this paper reviews effective analytical methodologies available to perform in-depth characterization of both innovator a…

Article Master the basics of UNICORN™ method editing with a free online course
Review the basics and learn how to use predefined phases to simplify method setup. It's a 30 minute course and you will receive a certificate when you finish. Enroll for free.

Article Generate an Automated Purification Protocol in Three Steps Using Predefined Methods

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