The biopharmaceutical industry urgently needs a more sustainable, cost-effective, and scalable downstream process for monoclonal antibody (mAb) production. Current protein A-based platforms are expensive, buffer-intensive, and unable to meet rising global demand—especially in low- and middle-income countries. A fully continuous, precipitation-based process offers a transformative solution by reducing costs, increasing throughput, and improving environmental sustainability, while maintaining product quality.
The project meets industry needs by developing a fully continuous, precipitation-based downstream process for monoclonal antibody production. It replaces costly, unsustainable protein A methods with a scalable, automated system that improves yield, reduces buffer use, and enhances environmental and economic sustainability. The project builds upon the successes of PC4.1-105 and involves a three-part strategy: Instrumentation and Automation, Supervisory Control and Optimization, and Commercial Scale-up.
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Rensselaer Polytechnic Institute
AstraZeneca
Boehringer Ingelheim
Bristol-Myers Squibb
ChromaTan Corporation
Dyadic International Inc
EMD Millipore Corporation
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC
PAK Biosolutions
Sanofi
