Strategy to mitigate aggregation during Protein A chromatography and low pH virus inactivation for a nivolumab biosimilar candidate

• Published in: Journal of Chromatography A Vol. 1743; p. 465698
• Main Authors: Pargas-Ferrer, Elizabeth, Chang, Sum Lai Lozada, García, Katia, Azaharez, Ernesto, Palacio, Julio, Mena, Midalys Cabrera, Boggiano-Ayo, Tammy
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 22.02.2025
• Subjects: affinity chromatography; Animals; Antibodies, Monoclonal - chemistry; Antibodies, Monoclonal - isolation & purification; arginine; bioactive properties; Chromatography, Affinity - methods; Glycine - chemistry; histidine; Hydrogen-Ion Concentration; immunoglobulin G; mannitol; molecular weight; Monoclonal antibody; Nivolumab; Nivolumab - chemistry; polysorbates; Protein A affinity chromatography; Protein Aggregates; Protein aggregation; Protein purification; sodium citrate; sorbitol; Staphylococcal Protein A - chemistry; sucrose; trehalose; urea; Virus Inactivation; viruses; Protein aggregation; Monoclonal antibody; Protein purification; Nivolumab; Protein A affinity chromatography

•Nivolumab shows strong pH-dependent aggregation during Protein A elution.•Effect of nine additives to Protein A elution for reducing aggregation was proven.•Protein A elution with mannitol, tween 80 or MgCl2 recover twice monomer as control.•Mannitol has a stabilizer role on anti-PD1 Protein A elut...