Peer-Reviewed Research

May 01, 2014
BioPharm International
Review regulatory requirements and the use of viral-challenge studies in drug development.
Apr 01, 2014
BioPharm International
The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
Mar 01, 2014
BioPharm International
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.
Feb 01, 2014
BioPharm International
Accurate protein concentration results can be obtained using standard spectrophotometers and commercially available short path length absorption cells.
Jan 01, 2014
BioPharm International
Criticality is used as a risk-based tool to drive control strategies.
Dec 01, 2013
BioPharm International
Criticality is used as a risk-based tool to drive control strategies.
Nov 01, 2013
BioPharm International
A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.
Oct 01, 2013
BioPharm International
The correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.
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