In this webinar, you will learn:
Trace amounts of host cell proteins can be present after the production and purification of any biopharmaceutical. Detection of these species requires highly specific techniques to accurately quantify even low levels of contamination. Host cell protein impurities, present at PPM-levels in biotherapies, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. Their complex and diverse nature makes them challenging to detect or monitor. With acceptance criteria for host residual DNA usually set at a very low level (often ≤1.0 pg of DNA per mg of drug substance), effective removal techniques and sensitive methods of HCP detection are critical.
Antibody-based techniques, like the enzyme-linked immunosorbent assay (ELISA), have been used to assess the HCP load of biotherapeutics before and after process changes. However, these techniques do not necessarily detect qualitative changes in the HCP population. In this webinar, we will discuss how mass spectrometry (MS)-based approaches coupled with ELISA methods help detect qualitative and quantitative differences in HCP populations.
Product Characterization Technical Specialist
Omar Lamm is responsible for field technical support of product characterization services. Based in Ann Arbor, Michigan, he has 20 years of experience supporting contract biopharmaceutical product development both in the lab focusing on mass spectrometry and full-scale analytical development programs, and in field client support.
Piotr Kaczmarek, PhD
Principal Scientist, Analytical, Testing R&D Services
Dr. Piotr Kaczmarek joined the organization 2013 to focus on the execution and development of analytical assays. He earned his MSc and PhD in Chemistry at the Faculty of Chemistry at the University of Wroclaw in Poland. He completed his postdoctoral training at the Massachusetts Institute of Technology in Cambridge, MA and the National Cancer Institute in Frederick, MD.