We will develop, build, and operate an integrated continuous cGMP production facility for mRNA at pilot scale that will also provide a template for commercial production. This will be a platform technology that could be used across the board for mRNA production, and the project will provide significant outreach among the industry and technology transfer with the aim of reducing the barriers – technical and regulatory – to the adoption of these technologies.

We will develop integrated, automated, and controlled continuous protein purification systems based on precipitation. The feed to the experimental systems will be monoclonal antibodies (mAbs) in crude, harvested cell culture fluid (HCCF), and the product would be in the form of particles of high molecular purity. Two precipitating reagents with orthogonal mechanisms, polyethylene glycol (PEG) as a volume excluder and zinc chloride (ZnCl2) as a cross linker, were examined in a high throughput screening format with mAbs in both purified and harvested cell culture fluid (HCCF) formats.