Purification groups have been facing challenges in three key areas as a result of the trends in the biotechnology industry: (1) Technical – the introduction of more complex and diverse modalities have increased the burden on development groups, (2) Financial – lean initiatives and reduced development timelines have led to more projects with fewer resources, and (3) Logistical – Mergers and acquisitions have created complex global business structures that make efficient coordination between development groups difficult. To address these pressures, the Purification Development groups at three Sanofi sites (US, France, and Germany) have completed a harmonization effort to develop a modernized platform approach for the purification of a range of potential modalities. These data-driven efforts leveraged historical experience and high throughput technologies to evaluate and, ultimately, narrow our library of separation chemistries and process architectures. Through this work we have generated cross-over data to assess the reproducibility of results, and completed a blinded, cross-site validation experiment to determine whether the harmonized approach was applied similarly. Throughout this platform development exercise, significant care was taken to understand organizational, historical, and cultural differences across all participating sites, ensuring that we would reach a harmonized platform in a way that encourages continued engagement and sustainable follow-through.

Development and implementation of a harmonized purification platform for a modern, diverse pipeline

2019 Spring National Meeting

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