Evaluation of the In-Use Stability of Monoclonal Antibody IV Admixtures Prepared from Drug Products Containing Polysorbate 20 Degraded by Host-Cell Lipases.

Host-cell lipases can be present in monoclonal antibody drug products and can degrade polysorbates present in the formulations as stabilizers. We hypothesized that the in-use stability of the IV admixture prepared from such a drug product might be impacted by decreasing levels of polysorbate 20. Host-cell lipase activity has, in fact, been observed during development of one of our therapeutic monoclonal antibody drug products.

Thiolation of Q295: Site-Specific Conjugation of Hydrophobic Payloads without the Need for Genetic Engineering.

Site-specific conjugation technology frequently relies on antibody engineering to incorporate rare or non-natural amino acids into the primary sequence of the protein. However, when the primary sequence is unknown or when antibody engineering is not feasible, there are very limited options for site-specific protein modification. We have developed a transglutaminase-mediated conjugation that incorporates a thiol at a "privileged" location on deglycosylated antibodies (Q295).