Successful development of biopharmaceutical products depend on accurate and thorough characterization of the molecule in formulation solution. Characterization of a formulated biotherapeutic requires a rigorous assessment of the molecule's stability.  Stability of a biotherapeutic includes biochemical, structural and colloidal stabilities. All stabilities can be assessed using a variety of techniques. Recent improvements in traditional technologies, development of new methods, and advancements in computer science have created excellent innovation opportunities for development of high throughput analytical and stress methods.In this presentation, high throughput formulation screening techniques are described according to their applications during biopharmaceutical discovery, development and manufacturing. The characteristics obtained by characterization methods include structural integrity, viscosity and aggregation propensity under different stresses. Analytical methods include mass spectrometry, size exclusion chromatography, dynamic light scattering and differential scanning fluorimetry. Stress methods include high and low temperature exposure, mechanical agitation and different formulation conditions such as pH, ionic strength and presence of various excipients. Large amount of data obtained by formulation screening allowed us to design comprehensive formulation space with well-known and well-predicted stability properties. The power of statistical analysis and design of experiment approaches is illustrated with several case studies.

Methods for high throughput formulation screening of monoclonal antibodies

245th National Meeting (2013)

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