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BIOPROCESSING
The digital age of bioprocessing and how manufacturers are benefitting from advancements in the sector.
STREAMLINING
BIOPHARMA MANUFACTURING
D Author: KEVIN SEAVER - general manager, Bioprocess Automation and Digital, Bioprocess Program at Cytiva
iscovering and making a new drug can take up to 10 years before regulatory approval. We have an opportunity to use tools in the digital world to shrink this timeline dramatically, but our industry is slow to take advantage. This is partly due to cybersecurity concerns as well as clinical and regulatory changes, but we can mitigate risk by turning custom bioprocessing projects into products. Without this advancement, the industry will fail in its responsibility to improve human health. Companies can mitigate some of this risk by engaging early with drug manufacturers and using laboratory and testing facilities to lay the groundwork for the complicated processes involved. Lessons learned from the labs and testing facilities can be transferred and scaled up for a full-scale manufacturing plant. The standard operating procedures (SOP) for bioprocessing plants currently require custom designed
The future of bioprocessing lies in equipment that harnesses digitised records for realtime analytics and predictive analysis and maintenance.
software and firmware that run bioprocessing equipment. In a highly regulated and audited industry, the financial and time investments needed to write and validate code for these projects can be immense. Even using some standard code base, the scope of a project can change rapidly as the development process advances. Turning custom bioprocess projects into standardised products allows customers to choose from a catalogue of hardware which can be integrated with other functions in the manufacturing process. Having bioprocess equipment that is more of a product than a project that has already completed the development cycle, and that fits the functional and user specifications, allows manufacturers to pre-test the equipment in a variety of environments and provide clear documentation and validation ahead of an expensive project. Instead of having to plan a new manufacturing system from the ground up, changes from developers can be accommodated relatively easily as only the updated parameters would need to be validated rather than the entire system. Extensive pretesting increases the overall quality of the system because of the comprehensive equipment testing required, which helps deliver nearly off-the-shelf bioprocess manufacturing
capabilities. Another benefit of bioprocessing equipment products is a reduction in time to set up a bioprocess plant. It no longer takes years to design, test, update, and re-test equipment as all of the testing and regulatory hurdles have been passed before the project begins. With the use of bioprocessing equipment products, records can easily be digitised and integrated. In this digital age, paper remains a constant in drug manufacturing, and the development of a single product can produce hundreds or thousands of paper documents. The transition to digital not only reduces some of this material production but makes records easier to audit and track. This helps speed up the validation of systems and can reduce time to product release down to months or even days. Additionally, digitising records allows manufacturers to apply a deeper analysis or simulation than they would normally get from paper documents. Bringing drug development into the digital age also allows for the use of digital twins – a virtual representation of a real-world plant or piece of equipment – a testing simulation which has been used in other industries over the last decade. Digital twins allow technicians to test various parameters to reduce costs, proactively anticipate issues, and optimise performance. The goal
