There have been many recent advances in biomanufacturing, but access to high quality biologics in the developing world, in emergent situations, or on the battlefield is still extremely limited. Due to limited cold-chain infrastructure and the unpredictable demand of these circumstances, there is a need for small-scale, on-demand production of biologics near the point of care. We have demonstrated a bench-scale, integrated and automated platform capable of rapid production and purification of multiple protein therapeutics. We utilize perfusion cultivation of <i>Pichia pastoris</i> to expand biomass and produce a protein of interest within 48 hours. The perfused material is immediately purified on an automated purification system using a molecule-specific 2- or 3-step chromatographic process. Each step in the purification process is automatically triggered, enabling completely hands-free multi column purification. System components such as columns and buffers are easily interchanged, allowing highly modular processes for purification to match specific drug products. To date, this system has been used to reproducibly manufacture high-quality human growth hormone (hGH), granulocyte-colony stimulating factor (G-CSF), and interferon-α2b (IFN-α2b) in an integrated, automated manner. We believe this simplified user experience, particularly for downstream unit operations, is critical in achieving reproducible product quality in logistically demanding circumstances.

Development of an integrated, automated, multi-product platform for the rapid production and purification of protein therapeutics

253rd National Meeting (2017)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.