Although we often hear about the benefits of bioprocessors moving from batch-based to continuous methods, quantification of the improvements is less common. In a recent review article, though, Sarfaraz Niazi, PhD, CTO at ABYOLO, a biosimilars company headquartered in Unterägeri, Switzerland, examined “the technical, economic, and regulatory aspects of implementing continuous manufacturing specifically for recombinant protein production and biosimilar development, synthesizing validated data from peer-reviewed research, regulatory sources, and global implementation case studies.”
As Niazi points out, it’s easier to talk about a transition to continuous methods than to do it. For example, he explains that continuous processing requires a sophisticated control strategy that includes real-time monitoring rather than just testing a product at the end of bioprocessing.
“The control strategy must demonstrate the ability to detect, respond to, and correct process deviations in real time while maintaining product quality within predetermined specifications,” Niazi explains. “This requires the implementation of sophisticated process analytical technology, advanced process control systems, and comprehensive material diversion strategies for managing out-of-specification materials.”
Despite the complexity of an overall control strategy when moving from batch to continuous processing, Niazi says that the biggest technical challenges arise downstream. Instead of the discrete downstream processing in batch methods, capture and filtering steps need to be continuous. As one example, Niazi mentions that “periodic counter-current chromatography has emerged as the leading technology for continuous protein capture chromatography, offering significant advantages over traditional single-column batch processes.
Given all of the challenges of moving to continuous bioprocessing—and just a few are discussed here—is it worth the change? According to Niazi’s analysis, it is not only worth the change but also beneficial enough to make it nearly mandatory to consider.
As Niazi sums it up: “The analysis demonstrates that continuous manufacturing offers substantial benefits, including a reduced equipment footprint of up to 70%, a 3- to 5-fold increase in volumetric productivity, enhanced product quality consistency, and facility cost reductions of 30–50% compared to traditional batch processes.”
Most businesses might consider such potential benefits beyond belief. Going from batch to continuous bioprocessing is not an easy task, but the numbers confirm the economic value in making the journey.