Center of Excellence in Host-Cell Protein Analysis

Performance Period: 1/1/2018 to 6/30/2019

The analysis of host-cell proteins (HCPs) is a route to more fine-grained insights into cell culture and purification of existing products and is likely to aid development of new modalities such as cell therapies. Proteomics technologies, particularly liquid chromatography – mass spectrometry (LC-MS) approaches, enable HCP analysis, and their availability will allow more routine characterization of HCPs that may pose challenges to the industry and development of new methods for HCP analysis. Delaware proposes the creation of a NIIMBL Center of Excellence in HCPs that will support the development and testing of state-of-the-art and emerging methods for HCP analysis using mass spectrometry. Such a Center will also serve as a NIIMBL "core facility" for performing HCP analysis in support of NIIMBL Projects and Organizations. Such support may include, but is not limited to: A) providing HCP analysis services to partners (e.g. academic, Tier 3 industry, etc.) on a fee-for-service mechanism, which is likely to require significantly less expense than third-party analyses; B) supporting projects that rely on HCP analysis (where analyses will be done by the Center of Excellence or as a complement and benchmark to such analyses from partners); C) testing various methods that may be applicable to emerging LC-MS approaches; and D) developing methods that will be leveraged in defining standards for routine testing in the industry. Moreover, such a Center will serve as a repository for identified HCPs, which will lead to the creation of either a NIIMBL-specific, or a publicly-available, database of all identified HCPs and their significance in bioprocessing. This activity will also leverage the University of Delaware's role in maintaining the CHO and Chinese hamster reference genomes. This activity will be led by Prof. Bramie Lenhoff.