Biopharma needs better sensors to realize the full benefits of data driven manufacturing, according to the director of the soon to be expanded Jefferson Institute for Bioprocessing.

In March, Thomas Jefferson University announced plans to add 40,000 square feet of additional academic and training space at the Jefferson Institute for Bioprocessing (JIB) training and education facility in Lower Gwynedd, PA.

Staff with industry 4.0 expertise are in high demand because biopharma is moving in a digital direction, says Parviz Shamlou, PhD, JIB executive director.

“Biopharma 4.0 promises improved compliance, increased productivity, efficiency, and robustness of existing processes and manufacturing operations,” he explains. “Also, using next-generation cyber-based platforms, bioprocess scientists and engineers will be able to develop new processes and operations to manufacture products that were previously difficult to make, creating new therapeutics that are safe and affordable for disease with unmet needs.”

In addition to helping biopharmaceutical companies expand their therapeutic horizons, industry 4.0 also makes it easier to comply with growing regulatory demands for more detailed quality and efficacy data, adds Shamlou.

“Regulatory agencies require assurance of product safety and efficacy. For a biopharmaceutical product, safety and efficacy are demonstrated through clinical trials and subsequently guaranteed by the manufacturer through an agreed upon set of tests which are carried out on the drug product from ever batch before it is released,” he says.

“The release specification translates to a set of critical attributes of the products which need to be monitored and controlled throughout the process. An important part of this approach is that the product release specification is only as good as the process that is used to manufacture it. Any changes to the process may introduce additional attributes not included in the release specification. This would be uncreatable.”

Understanding the true impact of process on product through application of Biopharma 4.0 is the ultimate goal of digital biomanufacturing, Shamlou tells GEN, noting “That is the future.”

Sensing the change

As well as more expert staff the industry also needs more effective real-time monitoring and data collection technology, says Shamlou, pointing out that the lack of such systems has held back adoption of the industry 4.0 approach.

“Industry 4.0 is not new. Other manufacturing sectors have been using digitally advanced cyber-based technologies, including artificial intelligence and augmented reality for more than a decade,” he says. In that respect, biomanufacturing has been slow in adopting the new technologies, partly because of the complexity of biopharmaceutical products and biologics, and their sensitivity to even minor changes to process conditions, according to Shamlou.

But things are changing.

“As the biomanufacturing industry moves forward into a post COVID-19 era, we need to develop new sensors, and adopt new technologies that can reliably and reproducibly measure critical attributes of biopharmaceutical products. Reliable calibration-free sensors for measurement of product quality attributes as well as process parameters would be a major step forward,” he says.

Better sensors enable better modeling and ultimately more effective process development, explains Shamlou, citing so-called digital twins—in silico recreations of unit operations—as an example, as they allow engineers to test processes in ways never been done before, reducing time and cost of development.

“Bioprocess scientists and engineers at JIB are starting to use mathematically based, Incomputational fluid dynamic (CFD), and other modeling and first-principle methods, to create digital twins of real processes including, for example, the cell culture process in a bioreactor and purification in a chromatography column,” says Shamlou.

“These digital twins are in their infancy but promise a major step forward towards full implementation of digital biomanufacturing.”

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