In many ways, control lies at the heart of bioprocessing, especially Bioprocessing 4.0. Nonetheless, bioprocessors face many control-related challenges according to a review article by Anurag Rathore, PhD, coordinator of the DBT Center of Excellence for Biopharmaceutical Technology at the Indian Institute of Technology Delhi in New Delhi, India, and his colleagues.

“The article aims to showcase that process control needs to be given more attention than it is presently,” says Rathore. “This is so because significant advances have been made recently in empirical and mechanistic process modeling, data analytics, and controllers.”

As Rathore makes clear, even more complex tools lie ahead. “Researchers are proposing advanced process-control strategies, from cascade to adaptive to hybrid, along with the introduction of neural network–based controllers,” he says. “There are also efforts to create a digital twin of the entire bioprocess, a task which would not be possible a decade ago.”

Advances in bioprocessing devices also impact the potential for control. “Automation in manufacturing would provide substantial opportunities to overcome many of the challenges faced in commercial success,” Rathore says. “However, inadequacy of standardization across software, hardware, and design specification continues to be a major hurdle.”

Getting tools to talk to each other is nothing new in technology, but a bit disappointing that it remains a hard hurdle to get over in bioprocessing.

As bioprocessing matures, many experts and companies will search for ways to take more control. As an example, Rathore concludes: “The paper is of great interest to biomanufacturers, particularly those engaged in doing continuous processing as these are the challenges they are likely facing or will face as they reach the implementation phase.”