CASSS MS 2024 -- Formulation development is a crucial element of biopharmaceutical development, to maintain structural integrity whilst minimising the level of post-translational modifications (PTMs). Labcorp has developed a standardised workflow for formulation development. Following a design of experiments (DoE) study on thermally stressed pembrolizumab, a potential stability issue with glycation was identified. In this study, the effect of formulation on glycation and the effect of glycation on antigen binding were assessed in the forced degradation of lead formulations phase. The study also gave the opportunity to test the feasibility of an LC-MS multi‑attribute monitoring (MAM) method for monitoring glycation.

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