Manufacturing, Lyophilization

Apr 01, 2016
BioPharm International
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
Dec 01, 2015
BioPharm International
Mechanical tests complement visual techniques for the post-processing characterization of freeze-dried products.
Aug 01, 2015
BioPharm International
The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
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.
Mar 01, 2014
BioPharm International
Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.
Jul 12, 2013
By BioPharm International Editors
Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.
Mar 01, 2013
BioPharm International
The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.
Mar 01, 2013
BioPharm International
Optimized freeze-drying cycles can offer scientific and business advantages.
Oct 01, 2012
BioPharm International
Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
Jan 01, 2012
BioPharm International
The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.
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