BioGenes wants to thank the organizers and all participants of the virtual BEBPA Host Cell Protein (HCP) Conference 2020. We very much enjoyed the fruitful HCP analysis discussions with experts from all over the world, and were impressed by the fantastic scientific presentations.
You missed out our presentation “Case Study – Comparison of Orthogonal Methods for Reliable HCP Coverage Determination“?
No problem! The presentation slides are available on request.
Please contact email@example.com.
In this talk, Dr. Pia Paarmann (Head of 2D Analytics), compared the detection of HCPs by using different orthogonal methods, such as 2D fluorescence Western Blotting, Immunoaffinity-Chromatography (IAC) and 2D DIGE or mass spectrometry (MS).
In the following, we summarize our impressions on key trends in HCP analysis and evaluation.
- ELISA is still the workhorse for routine HCP measurement, as it can be easily implemented into a GMP environment
- A strong focus lies on orthogonal methods for the characterization of antibody reagents and processes, such as IAC and 2D DIGE, or MS
- MS is preferable for the identification of problematic HCPs, but also supports downstream process development
- The calculation of absolute antibody coverage values depends strongly on the evaluation methods
- All the methods have strengths and weaknesses, and a wide range of orthogonal methods should be considered when developing HCP ELISA methods
Our conclusion is that HCP analysis is receiving more and more interest in the development and manufacturing of biologics. The reliable detection of HCPs is challenging, and there is no method that will always be suitable as a stand-alone. Although the HCP ELISA is still the gold standard, the application of different orthogonal methods should always be considered for achieving the most accurate HCP detection results.