Kevin Seaver, general manager, Bioprocess Automation and Digital, Bioprocess Program at Cytiva explores the digital age of bioprocessing and how manufacturers are benefitting from advancements in the sector.
Discovering 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 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 pre-testing 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 is to develop a “golden batch,” a benchmark for the most productive batch possible. With drug batches costing upwards of $1 million, there is little room for mistakes, and the digital twin model helps drive maximal improvements in yield.
These innovations mark a new phase of digitisation for bioprocessing plants. Most plants in the industry are – according to the Digital Plant Maturity Model (DPMM) – at level one or level two, meaning that they mostly run on paper records. Getting to a level three plant offers an increasingly automated system with more connectivity that requires standardised equipment that a standard bioprocessing equipment plant offers. This approach provides a high-quality plant that saves drug developers money because of its quick set up time.
A major challenge in digitising and automating these highly regulated drug manufacturing facilities is connecting them to the internet. Cyber security remains a primary concern because cyber-attacks can shut down an entire facility and cost millions to address. Cyber espionage and the security of proprietary information and processes is another concern. Taking a standardised approach is one way to address this with built-in security and extensive testing to validate a piece of equipment.
The future of bioprocessing lies in equipment that harnesses digitised records for real-time analytics and predictive analysis and maintenance. Standardised bioprocessing equipment allows for a rigorously tested plant to be put together in less time with higher quality outputs. As the industry continues to undergo a digital transformation, this platform offers integrated predictive capabilities and big data analytics that can help streamline the drug development process.