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Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.
This article was published in the July 2019 issue of Pharmaceutical Technology Europe
Digitizing manufacturing processes, and replacing paper-based systems with digital platforms, promises to improve the quality and efficiency of bio/pharmaceutical manufacturing, enabling companies to meet existing and future demands more effectively. One way digitization accomplishes this is by allowing operators to locate and use essential data in real time, to make smarter decisions on the fly. As the biopharma industry moves into precision medicines, this advantage will become increasingly important.
In addition, regulators’ calls to modernize drug manufacturing exerts more pressure on the industry to step up its game, and to harness the power of emerging technologies to prevent quality and compliance problems and costly product recalls (1). Manufacturing failures such as compromised sterility, the presence of mold in manufacturing areas, and contaminated containers have resulted in product quality problems and delayed product launches. Over time, they have worsened existing drug shortages and prevented patients from getting much needed medicines.
The push to modernize biopharmaceutical manufacturing has been intensified by the US Government, whose National Science and Technology Council’s (NSTC) Subcommittee of Advanced Manufacturing (SAM) issued a revised call to action in 2016, calling for manufacturers to employ advanced manufacturing methods and to train and employ a skilled workforce to implement these techniques (2). The report emphasized biomanufacturing, regenerative medicines, and the continuous manufacturing of pharmaceuticals as priority areas.
The report highlighted defined digital manufacturing and established it as a priority technology.
“Digital manufacturing is the use of an integrated, computer-based system comprised of simulation, three-dimensional visualization, analytics, and various collaboration tools to create product and manufacturing process definitions simultaneously. Design innovation is the ability to apply these technologies, tools, and products to re-imagine the entire manufacturing process from end to end,” according to SAM.
To help advance the goals stated in the report, the US Department of Defense (DoD) has established a public-private partnership with the Digital Manufacturing and Design Innovation Institute (DMDII), based in Chicago, IL. DMDII focuses on the enterprise-wide application of digital technology to enable highly integrated design and manufacturing of complex products with the goal of reducing time and cost while accelerating the pace of new products coming to market (2).
As industry, government, academia, and other groups seek to improve the production and quality of biotherapeutics, digitizing biopharma manufacturing processes will be a prerequisite for competing in the market in the future. Billy Sisk, life-sciences industry manager EMEA at Rockwell Automation, a Milwaukee, WI-based company specializing in smart manufacturing, shared insights with Pharmaceutical Technology Europe into automation trends and what will be required for biopharma digitization.
PTE: What factors are driving the trend toward automation in bioprocessing?
Sisk: Biotechnology and pharmaceutical companies are looking for new technologies and solutions that can help them remain competitive during demanding times. Cellular biology and gene therapy advancements have opened the door for smaller volume drugs, shifting manufacturing facilities to focus on multiproduct production. These facilities often require complicated batching, meticulous product tracking, and frequent changeovers.
Additionally, lifecycles have shortened, counterfeits have flooded the market, and there is pressure to get drugs to the market faster while still maintaining compliance and data integrity. Moving to automation in bioprocessing allows for increased production and improved decision making.
PTE: It seems that a next logical step following automation of the bioprocess is to digitize processes. Is that so, and why?
Sisk: Yes, this is definitely the next step for bioprocessing. With automation comes some level of connectivity. Pharmaceutical producers can build on that foundation to connect their systems horizontally and vertically, making more data available to improve decision-making, performance and compliance.
PTE: What are the benefits of digitizing aspects of the bioprocess?
Sisk: Companies can see an increase in flexibility, speed, and agility, which will reduce overall time to market. Additionally, digitization will give operators more visibility into their operations and enable them to make real-time decisions.
PTE: What are the challenges of digitizing in biopharma?
Sisk: A seamless transition to digitization calls for the correct systems and technology to be available and updated. Implementing a connected plant will not be possible with outdated systems. Knowing which systems may be needed and properly implementing them can be a big challenge, not only for the initial transition but also as operations continue to scale up.
Impact of digitization on bioprocessing
PTE: What role does your company play in the implementation of automation and/or digitization of bioprocessing?
Sisk: We’ve been working with customers to help them build their own facilities of the future, built on a modern distributed control system (DCS). We help them select and install the right solutions and equipment, including innovative technologies like augmented reality and advanced analytics. We also provide training to get employees up to speed on the new equipment and monitoring services to deliver backup support in case of any issues.
PTE: What current technologies and software exist in the industry today that facilitate digitization of the biomanufacturing process?
Sisk: A modern DCS, built on an open, unmodified Ethernet, provides smart docking stations and seamless plug-and-play connectivity for mobile equipment. It offers a starting point from which biotech and pharma companies can start connecting their facilities. The modern system offers the same capabilities of a traditional system, with information-enabled functionality designed for scalability. It also offers unified integration from ERP to the shop floor and provides real-time dashboards.
Visualization is also critical in order to maximize the accuracy and efficiency of a facility. Fixed operator screens or terminals are no longer practical. Instead, workers are more effective when they have tablets or mobile screens that can follow them, and production, throughout the facility. Two visualization technologies that companies can implement today are thin-client technology and augmented reality. Thin-client technology makes mobile visualization possible and helps reduce the risk of error that can accompany mobile equipment. And augmented reality provides a way to bring standard operating procedures directly to the operator, instead of having them look them up.
PTE: What impact does digitization have on workflow, especially the impact on human operators?
Sisk: Overall, digitization results in the need for less intervention and policing of workers, since the equipment is all connected.
1. Biovia, “How Can Biologics Manufacturing Process Improvement Benefit from Integrated Digital Solutions?” Blog, 3dsbiovia.com, June 28, 2016.
2. US Office of Science and Technology Policy, “Advanced Manufacturing: A Snapshot of Priority Technology Areas Across the Federal Government,” (National Science and Technology Council, Washington, DC, April 2016).
Pharmaceutical Technology Europe
Vol. 31, No. 7
When referring to this article, please cite it as F. Mirasol, “Can Bioprocessing Achieve Digital Transformation?” Pharmaceutical TechnologyEurope 31 (7) 2019.