How to document removal of a process related impurity

Question: How do I detect process-related impurity at low ppm levels? My company develops and produces a biologic. Recently, regulatory authorities asked...

Sep 25. 2019 | Ejvind Mørtz |
ELISA coverage

Can I use commercial HCP ELISA kits in clinical trial documentation?

Question: Does our generic HCP ELISAs have sufficient coverage? My company uses a commercial HCP ELISA kit for host cell protein analysis...

Jul 10. 2019 | Ejvind Mørtz |

What are Host Cell Proteins (HCPs)?

Question: What are HCPs and how are they measured? I recently met the term Host Cell Proteins (HCPs) in relation to process...

Jan 10. 2019 | Ejvind Mørtz |
1000 proteins quantified in e. coli mock lysate - HCP

Simple way to perform label-free quantification of Host Cell Proteins

Question: How can I improve label-free quantification of HCP?   I find it difficult to get an accurate label-free quantification of Host Cell...

Jun 25. 2018 | Ejvind Mørtz |
What is SWATH?

What is SWATH mass spectrometry and its advantages in HCP analysis?

Host Cell Proteins (HCPs) in protein biopharmaceuticals can be analyzed by the mass spectrometry SWATH analysis. It provides both identification...

Jun 22. 2017 | Thomas Kofoed |
Newsletter Subscribe to The Alphalyse Newsletter and get more
information on protein analysis methods and applications
© 2021 Alphalyse, Inc.