Analytical Best Practices

Jul 01, 2015
BioPharm International
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
Jun 01, 2015
BioPharm International
This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.
May 01, 2015
BioPharm International
The rapid testing of biologic raw materials can lead to greater efficiency.
Apr 01, 2015
BioPharm International
Care needs to be made to match the method of limit determination to the analytical method.
Feb 01, 2015
BioPharm International
Understanding the influence of change events on product performance is a necessity to routine drug development, transfer, and validation.
Nov 01, 2014
BioPharm International
The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.
Sep 01, 2014
BioPharm International
Design space generation is encouraged in new product development.
May 01, 2014
BioPharm International
Characterization of stability performance provides a clear, statistically defendable method for determining accelerated stability.
Mar 01, 2014
BioPharm International
Design of experiment is a powerful development tool for method characterization and method validation.
Dec 01, 2013
BioPharm International
Variation understanding and modeling is a core component of modern drug development.
native1_300x100
lorem ipsum