Traditionally, the drug industry has been reluctant to try new processes. The prevailing wisdom is that strict product quality rules and the complexity of modifying approved processes have made firms reluctant to innovate.
But biopharma is finally warming to the idea of digitized manufacturing, according to Duygu Dikicioglu, PhD, associate professor at University College London’s (UCL) department of biochemical engineering.
“I think there has been a huge paradigm shift in the sense that there is now ‘willingness’ to explore the potential of digitalization,” she told GEN. “The tools and the approaches (at least the ideas behind them) adopted today were more or less the same 20 years ago … but it would have been highly unlikely that biopharma would have shown as much interest back then to explore the potential of implementing these tools in their processes.”
The potential benefits of digitization and bioprocess 4.0 ideas changed biopharma’s mind, noted to Dikicioglu, who added that the ability to make better quality products, faster is hard to ignore.
“They will achieve robust, cost-effective, high quality and productive biomanufacturing via accelerated processes and cell line development, and advanced process control, without compromising on the simplicity of the process,” she explained.
The change in attitude is also impacting facility design, said Dikicioglu, who cited the vogue for multi-use plants that can be reconfigured as one of the main advantages of a willingness to embrace digitization.
“Perhaps the most immediate benefit I can think of is the adoption of dynamic and adaptable design spaces, in other words, tailoring the process to push for improving product quality,” she continued. “This could improve process flexibility.”
Challenges
Biopharmaceutical industry interest—combined with its lack of experience— in digitization is fueling the growth of specialist contractors, according to Daniel Bracewell, PhD, professor of bioprocess analysis at UCL’s department of biochemical engineering.
He pointed to companies like DataHow, an analytics and process modeling services firm; Insilico-biotechnology, a creator of digital twin models; and computer simulation specialist Gosilico, as an indication of the technical challenges biopharma faces.
“It is my belief that many of the bottlenecks are analytical as products get more complex and regulatory expectation to characterize them more completely grows,” he said.
According to Bracewell collaborative projects like Cadet—an open-source chromatography analysis and design toolkit—is further evidence of where biopharma firms interested in digital manufacturing need support.
Staff training is another area of need, said Dikicioglu, who added, the lack of engineers experienced in the use of advanced bioprocessing systems is a potential challenge for industry.
“The biggest bottleneck I can think of is the personnel; their training in readiness for the adoption of these new technologies is extremely important, and is lagging,” she explained.
Dikicioglu’s comments fit with the findings of a 2019 skills survey by Cell and Gene Therapy Catapult (CGTC)—an organization set up to support the sector by non-departmental government body, Innovate UK.
According to CGTC, 98% of the U.K. firms that responded said they planned to recruit more staff and of these, 83% thought hiring and retaining skilled staff “will be an issue for growth.”
