OR WAIT null SECS
May 01, 2017
This article provides an overview on important aspects related to bracketing strategies in Japan.
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
This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
December 01, 2016
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.
November 01, 2016
To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
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.
August 01, 2016
The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.
July 01, 2016
The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.
May 01, 2016
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.