Best Practices in Host Cell Impurity Analytics – Using Advanced Technologies and Methods to Monitor, Control and Quantify Host Cell Proteins

Learn about advances made in host cell protein (HCP) analytics. Current best practices that incorporate mass spectrometry methods for HCP antibody coverage analysis and HCP identification in quantification in biological drug substances will be discussed.

Register Free: https://www.biopharminternational.com/bp_w/host-cell-impurity

Event Overview:

Host cell protein (HCP) analytics have come a long way over the last 25 years. We have gone from a “black box” type approach that produced semiquantitative numbers at best to groundbreaking mass spectrometry (MS) techniques that can identify every host cell protein in a Drug Substance sample. While the HCP ELISA is still semi-quantitative today, it is by no means a black box. We now have the tools to know exactly which HCP the assay can detect and which ones it will miss. We will discuss how the adoption of advanced technologies and methods for HCP analytics ensures that an HCP ELISA, whether it is a generic or a process-specific assay, is appropriate for use and allows data driven risk assessment to ensure the integrity and safety of a drug product. We will also present several case studies focusing on HCP antibody coverage assessment utilizing 2D PAGE- and MS-based methods. Additionally, data on Cygnus CHO Lipase Assay using stable isotope labeled peptides and PRM-MS absolute quantification method will be presented.

Key Learning Objectives:

• Walkthrough a brief history and advances made in HCP analytics
• Understand HCP ELISA selection and how to ensure the selected assay is appropriate
• Learn advanced methods for HCP antibody coverage analysis, HCP identification, and quantification in drug substance samples

Who Should Attend:

• Director Bioanalytical Sciences
• Principal Scientist or Technical Lead, Bioanalytical Sciences

Speaker:

Eric Bishop
Vice President for Research and Development
Cygnus Technologies

Eric Bishop is the Vice President for Research and Development at Cygnus Technologies. Eric leads the research and development team and is responsible for new product development and custom development services. Eric has over 25 years of experience in HCP analytics. Eric joined Cygnus Technologies in 2010, bringing a background in R&D for several biopharmaceutical companies.

Prior to joining Cygnus, Eric worked for AstraZeneca, formerly MedImmune, from 2002-2010. During his time there, he had multiple roles from HCP assay development and tech transfer to being Analytical Representative on CMC teams guiding projects from IND to BLA submissions as well as Head of New Technology Development group. Prior to AstraZeneca, he was at CropTech Development from 1998-2002, where he was involved in characterization of recombinant proteins produced in plants

Register Free: https://www.biopharminternational.com/bp_w/host-cell-impurity