Peer-Reviewed Research

Sep 01, 2018
BioPharm International
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Sep 01, 2018
BioPharm International
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
May 01, 2018
BioPharm International
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.
Jan 01, 2018
BioPharm International
The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
Oct 01, 2017
BioPharm International
This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.
Sep 01, 2017
BioPharm International
The control of biologics microbiological impurities, contaminants, and mimetics is evolving.
May 01, 2017
BioPharm International
This article provides an overview on important aspects related to bracketing strategies in Japan.
Feb 01, 2017
BioPharm International
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.
Jan 01, 2017
BioPharm International
This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
Dec 01, 2016
BioPharm International
This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.
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