Encountering pH sensitive antibodies in your bioprocessing step? Not able to apply low pH treatment for viral inactivation due to instability?
In this talk, we will demonstrate that the addition of sugars and polyols can be an effective and process-compatible strategy for reducing protein aggregation during low pH viral inactivation step. Our results showed that: The addition of sugars and polyols at 10 % w/v to the Protein A eluate during low pH incubation was effective in reducing aggregation in pembrolizumab (IgG4) and denosumab (IgG2). Polyols and sugars increase both conformational and colloidal stability of the mabs at low pH. These excipients are process-compatible with no impact to the dynamic binding capacity of CIEX column. Their compendia excipient status allows easy incorporation into the product stream, requiring no removal step, unlike solvent/detergent method.
Learning Objectives:
Upon completion, participant will be able to list effective excipients for mitigating aggregation of pH sensitive monoclonal antibodies during low pH viral inactivation
Participant will be able to understand the stabilization mechanism of excipients in reducing aggregation at low pH conditions
Participant will be able to expand their choices of viral inactivation treatment for pH sensitive proteins
