I'm pretty sure none of the guidelines apply to us
Post# of 148165
All these things don't apply for leronlimab:
Quote:
Use of two robust orthogonal virus clearance steps
for monoclonal antibody products targeting SARS-CoV-2 proteins
characterize the impact of amino acid changes, insertions, or deletions throughout the monoclonal antibody target protein to identify regions where changes specifically impact monoclonal antibody binding or activity
Sponsors should characterize the epitopes to which monoclonal antibody products bind
etc ...
These guidelines are for neutralizing antibodies that target SARS2 proteins.