The emergence of precision medicine promises improved, more targeted therapies for patients. It creates a significant challenge for manufacturing, however, as conventional manufacturing techniques for high quality biologics historically rely on centralized, large-scale production of drug to supply global markets for broad disease indications. To enable manufacturing capability compatible with precision medicine, we need the ability to produce high quality biologics at a small-scale, on-demand, and with minimal human intervention within pharmacies, hospitals or healthcare clinics. To this end, we have demonstrated a bench-scale, integrated and automated system capable of producing, purifying, and formulating high quality biologic drug in less than 80 hours without intervention. We have paired this system with a complementary, integrated approach for accelerated process development to make new, non-platform products on the system in 3-6 months. Our system includes modules for cultivation, multi-stage chromatography, and ultrafiltration / diafiltration, along with integrated sensors and system controllers. We utilize the yeast <i>Pichia pastoris</i> to capitalize on its fast growth to high cell densities, which facilitates shortened production timelines. Additionally, its small, active genome and high capacity secretory pathway enable accelerated strain development, and its low and consistent host cell protein burden enables rapid purification development. Combined with our production system in fast, at-scale process development and process qualification, we can drastically reduce process development timelines. To date, we have demonstrated the reproducible manufacturing of three high quality biologics on the system: granulocyte-colony stimulating factor (G-CSF), interferon-α2b (IFN-α2b) and human growth hormone (hGH). We believe that reduction in the timelines for process development combined with the ability to produce small volumes of high quality biologics on a fully integrated and automated manufacturing system could increase access to medicines where and when patients are in need.

Development of a pharmacy-scale, integrated, automated, multi-product platform for on-demand manufacturing of high quality biologics

255th National Meeting (2018)

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