Characterization of a formulated monoclonal antibody requires a rigorous assessment of the molecule's stability. Biophysical properties often determine not only molecular attributes and structural stability but also the connection to efficacy of the final drug product. During the early stages of drug development it is very important to mitigate any adverse effects that could result from the manufacturing process, storage, transportation and administration to patients. Here we present several applications of high throughput methods for biophysical characterization during early formulation development. Biophysical indicators of conformational and colloidal stabilities were correlated with aggregation propensity under different stresses during both short and long term stability studies. A high throughput method for viscosity measurement is also described as a significant part of formulation screening. Integration of design of experiment methodology, high throughput assays, and statistical analysis allowed us to determine the design space for optimal formulation conditions using a minimal amount of material and time.

High throughput biophysical characterization of antibody formulations

243rd National Meeting (2012)

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