Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data
Event Overview USP 1132.1 is a newly introduced chapter by the United States Pharmacopeia, effective from May 1, 2025. It outlines best practices for measuring residual host cell proteins (HCPs) in biologics using liquid chromatography–mass spectrometry (LC-MS/MS)....
Using LIMS to solve key laboratory challenges
Event Overview USP 1132.1 is a newly introduced chapter by the United States Pharmacopeia, effective from May 1, 2025. It outlines best practices for measuring residual host cell proteins (HCPs) in biologics using liquid chromatography–mass spectrometry (LC-MS/MS)....
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity
Event Overview USP 1132.1 is a newly introduced chapter by the United States Pharmacopeia, effective from May 1, 2025. It outlines best practices for measuring residual host cell proteins (HCPs) in biologics using liquid chromatography–mass spectrometry (LC-MS/MS)....
Translating small-molecule development to complex generics and biosimilars
An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics
Understanding the Differences Between Small-Molecule Drugs and Biotherapeutics: An Overview
Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities
Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles
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