📰 Monoclonal Antibody HCP Challenges: The removal of host-cell proteins (HCPs) from bioprocesses is a challenge that scientists are still facing. The identification and characterization of these HCPs are important for manufacturing quality monoclonal antibodies (mAbs). Better ways to identify these molecules are needed, as well as solutions to remove HCPs that are hard to separate from free mAb. Product association and aggregate clearance are areas of further study. ⚗️🔬🧫
📢 Revolutionizing Monoclonal Antibodies: Conquering HCP Challenges
Introduction:
Host-cell proteins (HCPs) pose a challenge in the manufacturing of monoclonal antibodies (mAbs) as they can contaminate the product and threaten drug stability and patient safety. Scientists are looking for better ways to identify and remove these HCPs to improve product quality.
Main points:
- Despite advances in removing HCPs from mAb products, it is still a challenge to remove them completely.
- Efforts have been made to correlate the persistence of HCPs with their biophysical properties like molecular mass and isoelectric point, but no effective methods have been found.
- HCP abundance is an important factor as they don’t bind to mAbs strongly, suggesting that binding is more driven by mass action than binding affinity.
- To deal with HCPs that are hard to remove, sufficient washing and disruption of binding through additives and solution conditions may be necessary.
- Product association and aggregate clearance are focal points for further study in removing HCPs from mAb products.
Conclusion:
Removing host-cell proteins (HCPs) from monoclonal antibody (mAb) products remains a challenge. Efforts to correlate the persistence of HCPs with their biophysical properties have not been successful. HCP abundance and binding driven by mass action are important factors to consider. Further research is needed on product association and aggregate clearance to improve the removal of HCPs and ensure product quality.
