Search results for " structure determination"

Article Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost. By Mario DiPaola, …

Article Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration. By Cynthia A. Challener jijomathai/stock.Adobe.comAnalytical instrument…

Article Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation. Design of experiments (DOE) is a well-proven characterization approach within product…

Article Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…

Article Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization. The characterization of proteins involves identification of their complex …

Article Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics. In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…

Article Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins. By Adeline Siew, PhD  CA-SSIS/shutterstock.comIm…

Article Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics. By Susan Haigney Critical quality attributes (CQAs) are used in biop…

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

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