Associate Principal Scientist, Merck & Co.
BIOGRAPHY
DEC 19, 2018 5:00 PM CST
Challenges of Host Cell Protein Analysis with ELISA and How to Obtain Better Coverage of Your ELISA Antibody Reagents
Speaker
Abstract
DATE: December 20, 2018
TIME: 09:00am China Standard Time
10:00am Japan Standard Time
DATE: December 19, 2018
TIME: 5:00pm Pacific Standard Time
8:00pm Eastern Standard Time
Host cell protein (HCP) is a significant class of process-related impurity that needs to be removed to adequately low levels during the manufacturing of biological products to ensure product purity and patient safety. Due to its complex composition and low abundance levels in the final product, sandwich ELISA is often used as the workhorse for HCP testing for its high sensitivity and high throughput. However, the detection and quantitation of HCP by ELISA is highly dependent on the capture and detection antibodies used in the method and their HCP coverage. The primary challenge for the ELISA method, therefore, is to obtain specific anti-HCP antibody reagents that can potentially capture and detect all HCPs co-purifying with the biological product. Insufficient coverage from the antibody reagents used in ELISA may leave certain residual HCPs undetected in the final product, leading to immunogenecity and other product safety concerns for patients. Therefore, it is critical to generate process- or platform-specific anti-HCP reagents and qualify the reagents to make sure they have good HCP coverage.
In this webinar, we will discuss the approaches and steps to obtain reagents with good HCP coverage, from antigen selection for animal immunization, to the use of appropriate methods to determine the reagents’ coverage. We will also touch upon the overall HCP analytical control strategy that includes the use of methods orthogonal to ELISA for HCP characterization and analysis.
Learning Objectives:
-
Learn the impact of residual HCP to product quality, safety, and efficacy and the importance of HCP analysis.
-
Learn the challenges and limitations of HCP ELISA and why the ELISA reagents HCP coverage matters.
-
Learn the steps to obtaining reagents with good HCP coverage, starting with antigen selection for animal immunization
-
Learn the overall HCP analytical control strategy and risk management through orthogonal characterization.
This event will also broadcast on December 18, 2018 at 07:00am Pacific Standard Time, 10:00am Eastern Standard Time, 15:00pm Greenwich Mean Time, 16:00pm Central European Time. Click here to register.
You May Also Like
JAN 14, 2026 | 10:00 AM
Join us for an insightful webinar to discuss a holistic approach to testing for TB in a clinical setting. Tuberculosis remains a global health challenge and accurate, timely diagnosis is cri...
JAN 15, 2026 | 8:00 AM
Personalized medicine promises to significantly improve patient outcomes, but achieving this requires a deep understanding of human health and disease mechanisms at the molecular level. The...
JAN 20, 2026 | 11:00 AM
CAR-T translational research demands precise, reproducible, and scalable flow cytometry workflows. Manual centrifugation and antibody preparation steps remain major sources of variability an...
JAN 20, 2026 | 9:15 AM
Bloodstream infections (BSIs) remain a critical challenge in clinical care, where every hour of delay in diagnosis can significantly impact patient outcomes. This webinar explores findings f...
JAN 21, 2026 | 8:45 AM
C.E. CREDITS
Lipid nanoparticles (LNPs) have become the gold standard in non-viral gene delivery technologies, exemplified by the approval of the LNP messenger RNA (mRNA) vaccines against SARS-CoV-2. Sin...
JAN 22, 2026 | 8:00 AM
Cell line development (CLD) is often a critical bottleneck in biopharmaceutical production, often requiring labor-intensive workflows and multiple sequential screening steps that extend time...
DEC 19, 2018 5:00 PM CST
Share
Challenges of Host Cell Protein Analysis with ELISA and How to Obtain Better Coverage of Your ELISA Antibody Reagents
Loading Comments...