Biopharma has been slow to implement data-driven manufacturing. While the car and aviation sectors have used automated technologies on the factory floor for decades, the drug industry has been reluctant to invest. The issue, says Andrew Bulpin, PhD, head of process solutions at MilliporeSigma, is the way drug R&D is funded.
“Since the majority of investment in new product development goes into the upfront stages, biomanufacturers are hesitant to make any changes in the manufacturing stages given the heavily regulated environment,” he explains. “With so much invested in the upfront development, the risk of change and cost of investment has not been perceived as worth the reward, making them slow to adopt Industry 4.0.”
But attitudes are changing, according to Bulpin, who emphasizes that the benefits of next-generation bioprocess technologies have become hard to ignore.
“As these technologies have matured, been implemented, and proved their value in other industries, our research indicates that minds are changing, and that by 2025, approximately 30% of the molecules within commercial manufacturing will utilize process intensification technologies, with 90% of respondents realizing that they need to upgrade their digital capabilities to leverage new process technology,” he continues.
“This evolution will not happen overnight. We have begun to see the adoption in automation capabilities, both in terms of systems and plant-level automation. As biomanufacturers begin to implement some of these processes and gain more experience and benefits, they will get more comfortable with the concepts and capabilities of Industry 4.0.”
Push for quality
Regulatory demand for safer, more consistent biopharmaceuticals will also see more companies implement 4.0-enabled technologies. Biopharmaceutical processes are complex and highly variable in nature, notes Bulpin, and this can result in inconsistent and sometimes unpredictable process outcomes.
“To manage this complexity,” he advises, “in-depth knowledge and thorough understanding of the process and the various factors affecting process performance are critical. Knowledge management and process monitoring are important aspects of the process improvement efforts.”
“Industry 4.0 allows pharma companies to measure and control their processes by aggregating data from various sources all in one place,” he adds, citing his firm’s Bio4C ProcessPad data aggregation technology as an example.
With the introduction of advanced analytics that comes with Industry 4.0, “we can start thinking about moving in-line and real-time to actively control the process and produce high-quality products, faster,” he says, adding that in the future, the majority of biopharmaceutical facilities will be designed with data in mind.
“This paradigm shift and digital transformation of biomanufacturing processes will lead to a facility of the future that is an ecosystem of intensified, connected, and continuous processing,” he explains. “The convergence of advanced processing technologies with software analytics and automation allows greater understanding and control of products and processes. Leveraging data will allow for near real-time and better-informed decision-making, resulting in increased speed, quality, and flexibility, while reducing costs.”