Artificial intelligence and machine learning applications in biopharmaceutical manufacturing

Artificial intelligence and machine learning (AI-ML) offer vast potential in optimal design, monitoring, and control of biopharmaceutical manufacturing. The driving forces for adoption of AI-ML techniques include the growing global demand for biotherapeutics and the shift toward Industry 4.0, spurring the rise of integrated process platforms and continuous processes that require intelligent, automated supervision. This review summarizes AI-ML applications in biopharmaceutical manufacturing, with a focus on the most used AI-ML algorithms, including multivariate data analysis, artificial neural networks, and reinforcement learning. Perspectives on the future growth of AI-ML applications in the area and the challenges of implementing these techniques at manufacturing scale are also presented.