According to Josh Speer, associate director for digitalization technology at Thermo Fisher Scientific’s Single-Use Business Unit, Bioprocessing 4.0 is not a defined outcome when speaking to the value of the term in burgeoning area of clinical and basic science. But as a unifying umbrella to unite disparate activities, Bioprocessing 4.0 does acknowledge that the industry is looking for better ways of advancing new discoveries, he says.

“Bioprocessing today, when seen up close, can be surprisingly behind-the-times,” Speer continues. “The life-changing medicines that may spring from the world of bioprocessing discoveries have fueled us with a desire to do more. Adapting these technologies is the obvious way to make the world healthier, cleaner, and safer.”

He adds that the single-use technologies business model has been profoundly affected by Bioprocessing 4.0. “As a solutions provider to industry, customer demand for the technologies driving Bioprocessing 4.0 are shaping our products and our R&D efforts,” he told GEN.

Speer cites a bevy of new products: “Our open platform enables us to integrate customer-required sensors with our standard products. From a research perspective, our new offerings are being developed to support digitalization,” he points out. “For example, the touchscreen interface we now offer with single-use mixers provides an integrated control interface and supports the capability to monitor the single-use mixer in a supervisory control system.”

For Speer, another beneficial outcome of Bioprocessing 4.0 is a significant reduction in human error. “As a bioreactor automation provider, our TruBio control software is designed to support ease-of-use operations. Data are aggregated in the back-end and can be shared digitally, thereby reducing the number of opportunities for human interaction.”

He maintains that the sophisticated components of Bioprocess 4.0 are at the forefront of science and engineering. “The complexity of these technologies are challenges for quality assurance. This tension between innovation and certainty will be resolved only with a fundamental shift, a disruption, in our approach to these ideas.”

Speer spoke to the long standing disconnect between upstream and downstream bioprocessing, noting the fact that advances in upstream cell cultivation technology have moved more rapidly than downstream processing, isolation, and purification.

“In this context the Bioprocessing 4.0 movement to continuous processing is blurring the lines between upstream and downstream,” he notes. “The advances in upstream processing have brought it closer to the level of development seen in downstream processing—the biological uncertainty of cell culture has long lagged after the chemical determinism of chromatography.”

There is great concern over the ability of the industry to meet production goals forced by the COVID-19 threat and the need to ramp of production rapidly. Speer feels that the industry is ready to meet the challenge. “The wide-reaching impact COVID-19 is having on manufacturing is being somewhat tempered with the at-hand technologies enabling many people to work from home. Think high speed internet, powerful laptops, and cloud-based software,” he suggests. “The end result of an automated, configurable medicine supply system will allow rapid response to emergencies, especially the COVID-19 pandemic.”

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