What different types of bioassay are used for the quality check of a monoclonal antibody. How to check the quality of a biosimilar (monoclonal antibody) compared to its original molecule. The mAb in question here is anti-EGFR produced in CHO-S.
From my point of view, you need different bioassays for each target and for each antibody type. If someone could really answer your question, the manufacturing and approval (!) of biosimilars would be easy.
You will need to start with the basics.
Are the sequences the same, or not
Basic (not necessarily easy) biochemical comparisons of the molecules looking for oxidation/reduction differences, complex formation, glycosylation, solubility etc.
Then you can start to look at functional comparisons.
In my experience we were able to see small but consistent Fc effector differences between lots of the same antibody as well as slightly larger differences when compared to biosimilars made at different companies. The quality control people didn't like us, but I always thought the differences were functionally trivial, but they were consistent. Glycosylation was a big one.
Hope that helps.
Thank you all for your answers. I found this interesting article, http://www.tandfonline.com/doi/full/10.1080/19420862.2016.1264550