List view / Grid view

QA/QC

 

article

LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics

2 November 2018 | By

For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…

article

Integrating data from QC and Production to enable fast, informed decisions

2 November 2018 | By

Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…