Question: How is change control used to keep software validated?
Answer: It is normal that any system needs to be changed over time because of changes in business needs and software updates. The objective is to make sure that those changes are described properly, that the impact and risk of that change is well understood, and that there is documentation to support that assessment of the impact and the risk. A determination is then made regarding the degree of testing or revalidation work that would be required to re-establish that the system is still behaving according to its intended use in the process where it’s going to be used.
Polysorbate Analysis in Biopharmaceutical Applications — A Snapshot of the Analytical Toolbox
An overview of different approaches for the qualitative and quantitative analysis of polysorbates.
Detailed Glycosylation Analysis of Therapeutic Enzymes Utilizing Comprehensive 2D-LC–MS
January 3rd 2025In this article, the use of comprehensive two-dimensional liquid chromatography (LC×LC) coupled to mass spectrometry (MS) for characterizing glycosylation of therapeutic enzymes is presented.