In a webinar roundtable discussion, two leaders of the digital and automation team at Cytiva teamed up to discuss digital strategies for transforming therapeutic development in the 21st century. In this article, we summarize the talking points and resulting discussion between Christopher Long, Global Marketing Leader of Digital Solutions, and Christopher Sandusky, Director of Automation Solutions, Products and Life Cycle Management.
To watch the webinar in full, view the on-demand version.
What is digital maturity in biomanufacturing and why do you need it?
As drug development evolves, biomanufacturing is increasingly coming up short in the face of ongoing challenges—trial and error experimentation and paperwork wastes time and cost too much money. If the industry is going to successfully address the key drivers of change, including faster time to market, niche drug modalities, and increased agility, it will have to embrace digital transformation. But, how?
“Digital transformation isn't a new concept, but if we think about it in the context of all that has changed and all that is changing around us, biopharma certainly has some catching up to do,” Christopher Long says.
There are many benefits to going digital. “Digital transformation can help you go faster, be more flexible, and maintain a reliable process,” Long says. In the webinar, Long cites evidence that adopting digital technologies has allowed some organizations to go faster, be more flexible, and achieve increased reliability. “They’ve accomplished this by reducing deviations, reducing and depressing lead times, and lowering cost, while conversely increasing their productivity, increasing their capacity, and just as importantly, developing talent and leadership within their organizations.”
Digital is not just automation, however. It can be defined by in silico process development, including mechanistic modeling and digital twins; digitizing data with the use of manufacturing execution systems (MES), process control libraries, and eData; and maximizing investments with the help of augmented reality and virtual reality (AR/VR), digital work instruction, and predictive asset monitoring.
Strategies for your digital transformation
When it comes to the “how” of going digital, it all depends on where an organization starts—and, importantly, it is possible to start from any place, no matter how far advanced you are in your digital transformation. A company’s digital evolution varies based on organizational size, manufacturing scale, and digital maturity, says Christopher Sandusky.
In the webinar, Sandusky addressed some fundamental pain points that may be driving companies to go digital, including root cause analysis, GMP compliance, and data integrity and traceability. These bottlenecks draw on resources that “could have been doing something else in terms of maximizing productivity of the facility, getting greater throughput as well as just working to optimize your overall process,” he says. By increasing your digital maturity, you can start to address these pain points.
Sandusky talked about the 5-phase digital plant maturity model (DPMM), first described by the BioPhorum Operations Group in 2017 (1). It defines the stages of maturity of a biomanufacturing site, from paper-based plant to fully automated and integrated adaptive plant. Says Sandusky, “There's nobody that’s doing [phase 5] today and the technology isn't there, but it's meant to be fully autonomous self-healing, where if there’s an error with the machine, the machine itself will be able to fix itself.”
The phases of digital plant maturity are:
- Phase 1: manual, paper-based processes
- Phase 2: islands of automation (localized control)
- Phase 3: connected plant with MES, enterprise resource planning (ERP), and distributed control system (DCS)
- Phase 4: predictive analytics and real-time release
- Phase 5: fully autonomous, adaptive plant (aspirational)
Sandusky stressed a key point in implementing a successful digital transformation: Data strategy is crucial. To be useful, data should be contextualized with metadata. Companies need a clear data strategy to avoid amassing irrelevant or unusable data, and they need to be able to visualize and access the data to make sound decisions. Sandusky says it’s about “the decisions that you want to be making in the future and how you’re going to make those decisions.”
Regulatory considerations must also be considered differently than before. Regulatory bodies are increasingly open to digital innovations, with compliance with standards like 21 CFR Part 11 being essential for data integrity and traceability.
In summary, digital maturity encompasses more than just automating your manufacturing processes. To successfully implement digital transformation, companies should consider their pain points, assess their digital plant maturity, focus on data strategy, and engage with regulatory bodies to streamline compliance processes. In doing so, they will be able to harness the potential of digital biomanufacturing—and maximize productivity while optimizing processes.
- Digital plant maturity model (DPMM) v1: The development of a digital plant maturity model to aid transformation in biopharmaceutical manufacturing. BioPhorum Operations Group. February 17, 2017. Accessed July 2, 2025. https://www.biophorum.com/download/digital-plant-maturity-model-dpmm-v1-the-development-of-a-digital-plant-maturity-model-to-aid-transformation-in-biopharmaceutical-manufacturing/