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February 01, 2017
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
January 01, 2017
Excipient selection strongly influences lyophilization performance for biologic drugs.
October 01, 2016
An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.
September 01, 2016
This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.
July 22, 2016
The company manufactures biological drug products and intermediates for the allergy vaccine market.
April 01, 2016
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
December 01, 2015
Subjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.
August 01, 2015
The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
June 01, 2015
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.
March 01, 2014
Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.