With personalized medicine and niche drugs gaining momentum in the market, the biomanufacturing industry is evolving rapidly. To successfully grow with it, you must find ways to expand and diversify your business while maintaining quality, increasing flexibility, and driving efficiency. One way to do this is to take advantage of advancements in technology. By implementing automation strategies in single-use manufacturing, you can improve facility operations, data capture, and product quality.
As a growing contract development and manufacturing organization (CDMO) for biologics and advanced therapies Fujifilm Diosynth Biotechnologies (Fujifilm) recognized the criticality of flexibility and efficiency in manufacturing. When it expanded its College Station, TX, location, Fujifilm sought to install an automation solution in its new manufacturing facility, which is focused on efficiencies gained with the company’s Saturn™ mAb Solutions. The goal was to initiate seamless transfers across its facilities in the U.K. and U.S. from a small-scale to large-scale production environment. With scheduled commitments already in place with existing clients, adherence to a tight deadline was essential.
Through a successful implementation, Fujifilm was able to not only recognize the benefits an integrated automation platform offers but also the importance of working with an experienced partner who understands the unique challenges of the biomanufacturing space and has the commitment to provide multifaceted support network.
Selecting a partner for automation integration
Automation in a single-use biomanufacturing platform offers many benefits in an industry with high expectations and increasing regulatory scrutiny. However, if your automation solution provider cannot effectively marry its solution with your company’s specific needs, you will not be able to realize the full potential of automation integration. According to Elvin Vargas, director of automation/IT at Fujifilm, companies questioning the ability of a supplier unfamiliar with the complexities of bioprocessing to integrate automation into a biomanufacturing platform are justified in their concerns. “It is incredibly important the company standing by you has knowledge in both automation and process development,” he says. “There is no way you can automate something if you do not have knowledge about what you are trying to accomplish.”
To complete its automation project, Fujifilm selected Cytiva, a solution and equipment provider for the bioprocessing space. Cytiva uses Emerson’s recipe-driven DeltaV™ distributed control system in its FlexFactory™ single-use manufacturing solution, which was already in use in Fujifilm’s existing Texas facility. Once the two organizations collaborated on how to integrate Fujifilm’s existing bioreactors with Cytiva’s hardware and software, they were able to achieve increased flexibility and efficiency using a combination of automation and the modified ballroom design in the new facility. “When a company wants to change their process, they usually have to add or subtract equipment to make that happen, which can take a long time if the equipment is stationary,” explains Clifford Chambers, lead automation engineer, Cytiva, “With FlexFactory, they have the opportunity to buy the equipment as its needed and install it in their facility. When the software integrated into the equipment, you eliminate the need to hire contractors, which can sometimes be scarce.”
Start to finish, completion of the project took 12 months, which kept Fujifilm within the timeline it needed. During that time, Cytiva faced several challenges, such as having to work through the nuances of multiple purchasing partners for the equipment and coordinating orders that came in when funding was approved (and often not at ideal time points). In addition, Cytiva provided qualification and technical support, which allowed Fujifilm to limit the demand on its own resources, giving them time to focus on other value-added activities. “When you design your system, you need to account for any maintenance that will need to be performed on the system,” says Vargas about the importance of a partner’s track record for support during and after an automation integration project. “Look for a partner that will support all of your software and hardware upgrades throughout the life cycle of your system.”
Abandoning islands of automation to achieve one unified platform
Traditional manufacturing methods often rely on “islands of automation,” where each unit operation has its own dedicated measurements and local controllers. Fujifilm’s existing Texas facility had been utilizing this approach, which not only increased its need for resources and training but also reduced visibility across the entire manufacturing environment, limiting the ability to efficiently capture and analyze process data.
As today’s biopharma landscape continues to evolve, these limitations can become major issues as regulatory agencies are putting added pressure on companies to maintain safe, high-quality products. “When you have integrated automation on one unified platform, you can correlate your data from start to finish, regardless of whether you are using different equipment across a facility or even multiple facilities,” says Vargas. “Data is automatically populated, which eliminates the errors of manual entry, making it easier to access and analyze. By increasing visibility in processing and manufacturing, you can identify, investigate, and troubleshoot any deviations in your process more quickly, which helps preserve the intended quality and efficacy of your product.”
Increasing cost savings and control
A unified platform also facilitates product “recipe” transfers from one location to another. With multiple platforms, personnel have to physically travel between sites to transfer recipes, often having to train on new equipment. “When automation systems are not interconnected, a considerable amount of money and time must be invested in people and training to keep things up and running,” says Vargas. “A system using one unified platform can reduce costs and the need for human resources by almost 25 percent.” Now, Fujifilm is able to accommodate its manufacturing suites to its customers’ desires. “We can even put multiple customers in one room by using not just equipment but also automation to segregate them,” he continues. “We can create a new recipe for a customer based on our process development level authorities, and everything is controlled by the automation, mitigating the risk of mistakes as we execute their batches.”
Because Fujifilm Diosynth’s current bioreactors utilized the DeltaV platform, the company can now share data among all of its sites. For example, a process engineer at its North Carolina site can enter a basic procedure for how to create a product into the DeltaV system, and a process engineer in Texas can quickly access that recipe and make adjustments to match what they need to produce at their location. Chambers says the benefits of version control can also facilitate the correlation of changes, “Version control streamlines the change control system by allowing a process engineer to cross-reference changes that were recorded and saved on the DeltaV system by other process engineers.”
While an automation system offers a wide range of benefits, integration can be challenging, especially if your facility design does not have the flexibility necessary to adapt to unexpected design changes.
Think about automation early and design with your future in mind
The biggest need in the future of this industry is flexibility. There is a strong shift toward new technologies and approaches to manufacturing, and you must be able to grow with these changes. Design your facility to meet your short-term goals, but be cognizant of what kinds of products you plan to make in the future. Configuring a manufacturing facility with the ability to easily adapt to adjustments in a company’s goals is imperative.
“When companies are planning to add capacity to their sites, automation should be a point of talk on the first day,” says Vargas. “Regardless of whether it is a new or existing facility, you need to plan ahead to see how to integrate your new scope with your current system to be able to leverage that automation platform across your entire site. An integrated automation system provides a connection among your people, equipment, and all of your processes in one system. It also helps with the regulatory aspect of GMP manufacturing, which requires a product quality system for validation and data management.”
During facility design planning, Vargas suggests designating areas for multiple cables and outlets, even if the initial plan does not include equipment in that area. “For example, if there are three bioreactors in one area of a room but you decide later you want to move one, you are restricted to only the areas that have a connection to power, water, etc. if the design did not allow for flexibility,” he explains. The result is piping and cables stretched across the floor, creating unsafe work conditions for your employees. “Biomanufacturing equipment is mobile, but the automation system to connect it is not, so plan appropriately to ensure you can take full advantage of its capabilities.”
Flexibility is one of the many considerations you must make when preparing for automation integration in your biomanufacturing platform. A successful implementation requires a greater understanding of the technology, a significant investment in time and resources, and experienced guidance. In the end, though, you will have a modernized facility that maintains quality and improves productivity, giving you the speed-to-market advantage you need to remain competitive.