The Road Ahead—What’s Next for Host Cell Protein Analytics?

Advanced analytical strategies are transforming host cell protein (HCP) analytics. Learn how LC-MS quantification approaches enable accurate and precise HCP characterization beyond traditional HCP ELISA to improve process understanding and risk assessment.

Register Free: https://www.biopharminternational.com/bp_w/road_ahead

Event Overview:

Host cell protein (HCP) analytics have come a long way over the last 25 years—from a black box–type approach that produced semiquantitative data at best, to groundbreaking mass spectrometry techniques that can identify every HCP in a drug substance (DS) sample. Adoption of advanced LC-MS–based methods for HCP antibody coverage analysis and identification of HCP in the final DS samples ensure that an HCP ELISA is appropriate for use in each drug substance process.

While LC-MS remains the most effective approach for identifying host HCPs, the presence of DS-derived peptides can limit sensitivity as compared with total quantification by HCP ELISA. Full HCP characterization requires combining quantification strategies. Data-independent acquisition (DIA)–based relative quantification provides broad, global profiling of the total HCP population, enabling assessment of overall process trends and comparison across samples. In contrast, stable isotope–labeled (SIL) peptides deliver accurate, absolute quantification for selected HCPs of concern in final DS samples. Used together, DIA relative quantification and SIL-based absolute quantification create a comprehensive HCP analysis workflow. Along with HCP ELISA, this integrated approach improves both process understanding and risk assessment for biologics development.

Key Learning Objectives

• Discuss a brief history and advances made in HCP analytics.
• Learn advanced methods for HCP antibody coverage analysis and quantification by LC-MS.
• Understand when and how HCP analytical tools can be used during process development.

Who Should Attend

• Director, bioanalytical sciences
• Principal scientist or technical lead, bioanalytical sciences
• CMC leads
• CMC consultants

Speaker:

Eric Bishop
Vice President, R&D
Cygnus Technologies

Eric Bishop is the vice president for research and development at Cygnus Technologies. Bishop leads the research and development team and is responsible for new product development and custom development services. He has over 25 years of experience in HCP analytics.

Bishop joined Cygnus Technologies in 2010, bringing a background in R&D for several biopharmaceutical companies. Prior to joining Cygnus, he worked for AstraZeneca, formerly MedImmune, from 2002 to 2010. During his time there he had multiple roles, from HCP assay development and tech transfer to being the analytical representative on CMC teams guiding projects from investigational new drug (IND) to biologics license application (BLA) submissions; he also served as head of the New Technology Development Group.

Prior to AstraZeneca, Bishop was at CropTech Development from 1998 to 2002, where he was involved in characterization of recombinant proteins produced in plants.

Register Free: https://www.biopharminternational.com/bp_w/road_ahead