Analytical Methods

Feb 01, 2015
BioPharm International
As ADCs move through the drug-development process, different analytical methods are often required.
Jan 21, 2015
BioPharm International
A new study conducted by the National Institutes of Health found that a certain vector used in gene therapy (and its insertion site in the genome) may be associated with an increased risk of liver cancer.
Jan 01, 2015
BioPharm International
Ligand-binding assays are fundamental to characterizing biosimilars.
Dec 01, 2014
BioPharm International
The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
Sep 15, 2014
BioPharm International
By BioPharm International Editors
A Q&A on bioanalytical method integrity with Roger Hayes of MPI Research.
Aug 15, 2014
BioPharm International
Industry players form Allotrope Foundation to solve analytical data management problems.
Aug 15, 2014
BioPharm International
An automated analytical method determines the purity of chromogenic, fluorescently tagged proteins or metal-bound proteins.
Aug 15, 2014
BioPharm International
Development and validation of two pivotal assays for in-vitro comparability testing of insulin biosimilars.
Aug 15, 2014
BioPharm International
Methods must be suitable at each development phase, robust, and effective on multiple platforms.
Aug 01, 2013
BioPharm International
By BioPharm International Editors
Michael Rooney, director, bioanalytical development at Jazz Pharmaceuticals, provides an overview of a life cycle strategy for analytical methods development, the need for standards and guidance documents, and therole Quality by Design can play in method development.
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