Course Description:
Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell proteins (HCPs) are a significant class of process-related impurities that are coproduced with the desired product. USP General Chapter <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals includes detailed information on the design, validation, and implementation of reagents and immunoassays used to measure these residual HCPs. A new proposed chapter builds on <1132> and provides an overview of the capability of Mass Spectrometry (MS) methods for HCP identification and quantitation. This seminar will describe best practices for instrument selection, sample preparation, liquid chromatography (LC) separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods.
Who Should Participate:
Scientists, managers and regulatory experts responsible
for manufacture and testing of biologics destined for
clinical trials.
The live version of this recording took place May 31, 2023
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
Niomi Peckham
Director of Pipeline Development,
Global Biologics
United States Pharmacopeia
Ned Mozier
Vice President,
Biotherapeutics Pharmaceutical Sciences
Pfizer