Alphalyse A/S
Alphalyse helps biotech and pharmaceutical companies improve their understanding of the Host Cell Protein (HCP) in preclinical and clinical drugs. This knowledge enables better optimization of the downstream process for optimal removal of HCPs. If you would like to know more, visit our website
https://www.alphalyse.com/host-cell-protein-analysis/
If you would like to learn about our customer cases and follow our work within research of Host Cell Proteins you can follow us on LinkedIn: https://www.linkedin.com/company/alphalyse-inc./
Better vaccine purity and consistency –Best practice Host Cell Protein analysis by LC-MS
Experimental Comparison of 3 Quantitation Methods in USP 1132.1
USP initiatives for enhancing the quality and consistency of MS-based HCP analysis
Genmab webinar Part II: Experiences from an “off-ELISA” road
Genmab webinar Part I: Experiences from an “off-gel” road
Protect mAb stability: Control polysorbate-degrading HCPs
Q&A on LC-MS-based HCP analysis with CMC executive Bryant McLaughlin
Ensure process efficiency and consistency using data from 500+ projects of MS-based HCP analysis
Problematic Host Cell Protein impurities can stop your biologics program!
ELISA reagent characterization using advaced LC-MS methods
Bavarian Nordic Covid19 vaccine - how they implemented LC-MS-based Host Cell Protein Analysis
EM vaccine webinar Sep 2025 Use of USP methods YouTube
Analytical best practices on Host Cell Protein analysis as described in USP chapter 1132.1
Recent changes in regulatory guidelines for Host Cell Protein documentation in biopharmaceuticals
3 examples of biopharma clients who received regulatory request concerning HCP documentation
Experimental USP General Chapter 1132.1 method comparisons | Advantages and limitations
What do you do if LC-MS reveals problematic HCPs in your DS?
At what stage does Genmab suggest to use MS-based HCP analysis?
Demonstration of consistent HCP clearance at commercial scale | Genmab off-ELISA strategy part 4
Process changes – Assessment of harvest step | Genmab off-ELISA strategy webinar part 3
Process changes and comparability study of HCP profile | Genmab off-ELISA strategy webinar part 2
HCP characterization and process development | Genmab off-ELISA strategy webinar part 1
How often does Genmab experience problematic HCPs?
Bryant McLaughlin on FDA/EMA views upon MS-based HCP data
Handling unexpected process changes | Changing harvest filters
Genmab: The ELISA "Total HCP" number is arbitrary
Genmab Holistic MS-based HCP strategy
With ELISA-MS you don't need a null cell line to get the HCP coverage number
HCP characterization of in-process samples | Genmab webinar Part 1
Selection of commercial anti-CHO HCP reagents | Genmab webinar Part 2