Growing biopharmaceutical industry interest in data-driven production is impacting all parts of the supply chain. Which, when looked at from another perspective, means suppliers can determine whether drugmakers’ digitization strategies are a success. Analysis by Deloitte indicates that use of cloud, AI, and wearable technologies in the plant has increased markedly in recent years, particularly since the COVID-19 pandemic disrupted normal operations.
And biopharma’s willingness to use digital technologies is feeding back through the supply chain, according to Jonathan Royce, CEO of purification resin developer Bio-Works.
“The digitalization of data is a broad trend impacting every industry—not just drug manufacturers. For the suppliers that make manufacturing systems that include software, there is a clear need for standardization in data availability so that the drug manufacturers, who are integrating systems from many suppliers, can aggregate data in an efficient way,” says Royce. “For companies like Bio-Works, that supply consumable raw materials, the focus is on making data which is traditionally kept on paper available in a digital format. This can be everything from quality control data to tracking data for shipments.”
Fundamentally the move towards digitization is changing how biopharmaceutical companies interact with the technology developers and raw materials suppliers.
“Drug makers are asking suppliers to help them take non-value-added steps out of their manufacturing, so that they can maximize the utilization of their facilities for doing things that are actually on the critical path to the creation and purification of drug substance,” continues Royce. “Some recent examples for Bio-Works include our development of a desalting resin that does not need to be pre-swelled, and an IMAC resin that incorporates tightly bound nickel, which removes the need for metal loading prior to use.”
Even well established, mature bioprocessing techniques like chromatography are being rethought in the digital age. Royce says engineers are reaching for digital tools as companies seek to accelerate downstream process development.
“There are available solutions to most of the challenges that one might face—chromatography is a mature technique which is proven to be scalable and reliable so long as processes are well-designed from the start,” he tells GEN. “But the pressure on process development teams to increase project throughput does create risks that lack of characterization data leads to issues during scaleup.”
Royce cites in silico modeling as an example of a digital technique being used to address such issues, explaining “Mechanistic modeling has shown a lot of promise to allow in-silica modeling of process conditions to identify risk zones that should be experimentally explored more carefully.”
But whether this type of digital modeling becomes standard practice depends on a variety of factors, one of which being the supply sector’s willingness to innovate.
“The software used for modeling is quite proprietary and it would be ultimately beneficial to see more competition, either from the private sector or in the form of open-source solutions, to drive innovation in this space,” notes Royce.