Industry 4.0 technologies are tools CDMOs can use to meet customer needs, not an end in and of themselves. For some projects, traditional systems will be the better option and understanding this is vital. So says Sebastien Ribault, PhD, head, end-to-end solutions, life science business, Merck KGaA, who advocates for a technology agnostic approach to bioprocessing.
“It’s not just about offering these advanced technologies. We must be able to apply them in the appropriate operational context. Successful CDMOs know how to best utilize technologies to innovate throughout the entire drug development process, rather than solely focusing on one step,” explains Ribault. “It’s all about increasing speed without compromising on quality while staying flexible and adaptative. A CDMO must respond to the client’s request even at the last minute and 4.0 gives more options to do it.”
Responding to client requests, particularly those relating to manufacturing, is as much about understanding the project as it is about the technologies that are available, according to Ribault.
“Most of our customers leave the specifics with us, but that doesn’t mean that they don’t have any expectations on 4.0 technologies. We leverage our global network and deep expertise to assess our customers’ needs on a case-by-case basis,” he says.
For example, for processes designed to deliver large quantities of a product per year, 4.0 technologies are likely to reduce costs. However, this may not be the case for smaller-scale runs.
“For a process that needs to run once a year at small scale, the use of 4.0 technologies will cost more in process development and will likely be more expensive than fed batch,” Ribault tells GEN, adding that speed to market is also a key consideration.
“If time is of the essence, most of our clients will prefer to go for well-established technologies and a ‘no-risk’ approach and therefore won’t go for innovative approaches including 4.0 manufacturing technologies,” he continues
Despite these case-specific caveats, CDMO sector use of industry 4.0 technologies in general will increase, maintains Ribault.
“The convergence of advanced processing technologies with software analytics and automation allows greater understanding and control of products and processes,” he notes. “Leveraging data allows for near real-time and better-informed decision-making, resulting in increased speed, quality, and flexibility while reducing costs.”
Merck KGaA’s approach to connecting cell line development to manufacturing provides an example of how cost and time savings can be achieved, says Ribault.
“We use algorithms for sequence optimization and diverse DNA sequences to increase productivity. We are also using targeted integration tools for a more predictable outcome. Pharma 4.0 starts with molecular biology,” he points out. “The use of process data and AI goes from process development modelization to GMP manufacturing. Using N-1 perfusion bioreactors in a format that is compatible with contiguous manufacturing is one example of a recent innovation that is helping to reduce process time and costs.
“This has a direct impact on the `first in patient’ timing, which is reduced by the integration of new tools, AI, and fully integrated equipment trains.”