To maintain a competitive position in the biopharmaceutical industry, biotechnology companies need to continually improve the speed of product development and efficiency with which these products are manufactured. With the introduction of biosimilars and increasing pressure by payers to reduce the cost of products, this has become even more important for the industry. As has occurred in other industries, application of advanced computational tools, including mechanistic modeling, to process development provides the opportunity for improved process understanding and therefore the development of more robust and efficient manufacturing processes. With improved understanding around parameters that have the greatest impact, along with an understanding of the magnitude of these impacts, it becomes possible to fine-tune chromatography unit operations to optimize for desired outcomes. Using a targeted set of calibration experiments, we have employed mechanistic modeling to increase our understanding around an intermediate cation exchange purification step. Using this model, we explore process improvements targeting an optimal balance between yield, purity, and manufacturability.

Fine-tuning your purification process: Using mechanistic modeling of chromatography to optimize the balance between yield, purity, and ease of operation

255th National Meeting (2018)

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