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April 01, 2017
FTIR can successfully measure key characteristics of therapeutic proteins in a single step.
March 01, 2017
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
Process characterization and model building are essential skills and are required for modern drug development.
February 01, 2017
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
October 01, 2016
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
August 01, 2016
Experts discuss recent advances in cell viability testing methods in bioreactors.
July 01, 2016
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
June 01, 2016
Specification limits should be set early in drug development and refined in later phases as data becomes available.
May 01, 2016
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
April 01, 2016
The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.