Peer-Reviewed Research

Jul 01, 2015
BioPharm International
Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.
May 01, 2015
BioPharm International
Resonant mass measurement can be used to detect and quantify the formation of protein subvisible particles and to detect and quantify any silicone droplets in a formulation.
Apr 01, 2015
BioPharm International
Liquid particle counters are ideal for protein aggregation studies.
Jan 01, 2015
BioPharm International
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Dec 01, 2014
BioPharm International
The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
Oct 01, 2014
BioPharm International
By BioPharm International Editors
Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
Jun 01, 2014
BioPharm International
Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.
May 01, 2014
BioPharm International
By BioPharm International Editors
Review regulatory requirements and the use of viral-challenge studies in drug development.
Apr 01, 2014
BioPharm International
By BioPharm International Editors
The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
Mar 01, 2014
BioPharm International
By BioPharm International Editors
This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
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