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)....
25 February 2026
Translating small-molecule development to complex generics and biosimilars
On-Demand Presentation by Dr. Joseph Glajch (JLG AP Consulting)
An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics
On-Demand Presentation by by Dr Michael Dong (MWD Consulting)
Understanding the Differences Between Small-Molecule Drugs and Biotherapeutics: An Overview
On-Demand Presentation by Dr. Michael Dong (MWD Consulting)
Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities
On-Demand Presentation by Dr. Bingchuan Wei, MBA (Genentech)
Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles
On-Demand Presentation by Dr. Francisca Galindo Garre (Johnson & Johnson Innovative Medicine)
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
On-Demand Presentation by Dr. Anne Ries (Boehringer Ingelheim)
Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach
On-Demand Presentation by Dr. Pierre Lebrun (Cencora – PharmaLex)
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