Articles on analytical & statistical methods, process analytical technology - BioPharm International

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Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
March 1, 2014
Defining Quality Metrics is No Easy Task
February 1, 2014
Determining Criticality—Process Parameters and Quality Attributes Part II; Design of Experiments and Data-Driven Criticality
January 1, 2014
Metrics Sought to Ensure Drug Quality
January 1, 2014
Progress in the Prediction of Protein Aggregation
January 1, 2014
Understanding and Modeling Product and Process Variation
December 1, 2013
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
December 1, 2013
Thermal Protection for Control-Room-Temperature Products
November 1, 2013
Metacomplex Formation and Binding Affinity of Multivalent Binding Partners
November 1, 2013
USP Plans Standards on Good Distribution Practices
November 1, 2013
eBook: Troubleshooting Tips & Best Practices for Validation/Mapping
March 25, 2014
Peptide Mapping of Glycoprotein Erythropoietin by HILIC LC/MS and RP-LC/MS
March 25, 2014
Fast and Efficient Peptide Mapping of a Monoclonal Antibody (mAb): UHPLC Performance Using Superficially Porous Particles
March 25, 2014
TOYOPEARL AF-rProtein A HC-650F Host Cell Protein Removal
March 25, 2014
Agilent Bio-Monolith Protein A Monitors Monoclonal Antibody Titer from Cell Cultures
March 25, 2014
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