Search results for " analytical"

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 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 An Analytical Approach to Biosimilar Drug Development
Having an analytical strategy to compare the physicochemical properties of a biosimilar to its reference product can therefore provide important clinical data to indicate that clinical similarity exis…

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 Tools for Enabling Process Analytical Technology Applications in Biotechnology
In this paper, the authors review the various analytical methods that can enable use of PAT. A critical evaluation of suitability of each analytical method as a PAT tool in terms of sampling (in-line,…

Article The Lifecycle Change of Process Validation and Analytical Testing
…or, of Innopharma Labs in Dublin, about the impact FDA's 2011 process validation guidance has had on analytical testing and validation.  CONTINUOUS PROCESS VERIFICATION   Bi…

Article Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg from GE Healthcare presented the importance of implementation of a robust analytical control strategy to ensure drug product efficac…

Article Analytical SEC: How Does Back Pressure Relate to Resolution?
Let’s straighten out what really helps you achieve high-resolution analytical SEC data. Read paper

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
CE Capillary zone electrophoresis; an analytical method in which a mixture is fractionated using charge; analytes are detected using optical density, mass, or other physical properties. Also called CZ…

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