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July 17, 2014
Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein...
January 27, 2014
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental...
January 13, 2014
PDA’s Technical Report for Biotech Cleaning Validation
Cleaning validation plays an important role in reducing the possibility of product contamination...
January 11, 2014
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Once risk levels have been assigned to the CQAs, the next activity is to begin…
December 29, 2013
Quality by design for biotechnology products—part 1
Quality by Design (QbD) is a concept applied to the design and development...
October 4, 2013
Essentials in Establishing and Using Design Space
Design-space generation always begins with CQAs, risk assessments, definition of materials...
August 23, 2013
Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1),…