BEBPA Blog
2019 BEBPA HCP Conference Speaker
Speaker: Billy Wu, Chief Scientific Officer, BioAnalytix
Time: Day 1, May 15, 2019 at 4:00pm
Recent Publication
Nature Biotechnology
On-Demand Manufacturing of Clinical-Quality Biopharmaceuticals
Recent White Paper
Host Cell Protein Analysis in Biologic Drug Development
Host cell proteins (HCPs) are common impurities in biologic drug products and are an obligatory critical quality attribute (CQA). The individual protein contaminants that make up the HCP profile, however, may vary significantly among individual biologic products and expression systems. As such, the HCP profile must be analyzed to identify even low levels of potentially concerning species in a biologic drug to ensure safety and efficacy. This whitepaper reviews fundamental aspects of HCPs pertaining to biologic drug development and current and emerging approaches to HCP analysis.
Meet Dr. Billy Wu
Dr. Wu is Chief Scientific Officer of BioAnalytix. Dr. Wu developed his expertise in advanced analytics and biologic drug development with Genentech, where he spent nine years in areas of protein chemistry and advanced analytical methods for complex characterizations of biologic pharmaceuticals. After that, he further developed his analytic expertise with ThermoFisher Scientific where he worked in developing methods and applications of hybrid mass spectrometry in proteomics. During his time at the Barnett Institute, Dr. Wu focused on various advanced analytical techniques and methods for complex protein analysis and biologic drug characterization, including ETD for complicated disulfide characterization, LC-MS for biosimilar comparison mapping, and protein PK/PD characterization analyses using unique sample preparation techniques combined with hybrid mass spectrometry. Dr. Wu’s primary focus has been in applying these advanced analytical approaches in biologic drug development and regulatory strategies with multiple pharmaceutical and biotechnology companies in the US and abroad. He has published more than 70 scientific papers in these areas.
