BEBPA Blog
Tech Briefing: ELISA and USP 1123.1 Interest Groups at BEBPA’s 2024 HCP Conference
The 2024 Host Cell Protein Conference will feature two Interest Groups on Day 3 which will be available only to in-person attendees. BEBPA conferences are well-known for their collegiality, opportunities for networking, and speakers/attendees who “tell it like it is,” and this is due in large part to conference Interest Groups and Workshops.
The ELISA-based Interest Group, led by Catherine Shoemaker-Ramsey (Biogen), will focus on recent developments in the field. Presentations will seek to answer the following questions:
- How can one mitigate risk if using a commercial HCP assay, instead of process-specific reagents?
- How stable are ELISA critical reagents in long-term storage, and what are some ways to analyze them?
- Are there other ways to store the reagents instead of freezing them?
- How well do automated ELISA platforms work?
Talks being presented in this interest group include:
SureKit® Stabilized Host Cell Protein Assay Kits: A User-Friendly Alternative to Traditional HCP ELISAs and Frozen Reagent Storage
Mary Retzlaff, Chief Scientific Officer, Upkara, Inc
Long-term HCP Antibody Stability Analysis
Xing Wang, President, Array Bridge Inc.
Process-Specific Calibrators in a Generic Host Cell Protein ELISA
Andrew Hamilton, Senior Scientist Cytiva
Enhancing Efficiency and Flexibility in Host Cell Protein ELISA Through End-to-End Automation Using Hamilton Systems
Daniela Olszova, Research Scientist, Gilead Sciences Inc.
The USP 1132.1 Interest Group will discuss the imminent USP 1132.1 guidance chapter. HCP analysis by LC-MS/MS requires special consideration in the experimental design, execution, data analysis, and data reporting with multiple factors potentially impacting the reliability and reproducibility of LC-MS/MS analysis, especially when quantitative data are provided. The new USP chapter 1132.1 is meant to address the lack of best practices in using LC-MS/MS for residual HCP measurement across industry by describing the special considerations in establishing a robust LC-MS/MS workflow with steps starting from sample preparation to column separation, data acquisition, data analysis and all the way to properly reporting and interpreting the data.
The MS-based section of the Interest Group will focus on an overview of the special considerations on the use of LC-MS/MS methods for HCP identification and quantitation and cover best practices mentioned above as well as the orthogonality between LC-MS and ELISA methods and how to interpret the differences observed among the two methods. Multiple case studies will be provided to drive an interactive conversation and demonstrate best practices to utilize LC-MS at different phases of biopharmaceutical development. This interest group will be led by Fengquiang Wang (Merck), Ying Zhang (Sarepta), and Ned Mozier (Pfizer, retired).
Only one week left to register for BEBPA’s 2024 Hybrid Host Cell Protein Conference happening in College Park, Maryland on May 14-16! Can’t join us in person? Register as a virtual attendee!
