AGC Biologics described on Apr. 13 how modular, single-use bioreactor systems are changing strategies for biologic drug manufacturing by offering more flexibility and efficiency compared to traditional scale-up methods. The company’s approach was detailed in an interview with Anders Cai Holm Hansen, Principal Scientist, Customer Solution Design at AGC Biologics, published by BioSpace.
Traditional scale-up processes often require significant investment in large stainless-steel reactors and can lead to delays and higher costs when moving drugs from development to commercialization. AGC Biologics said its scale-out model uses multiple smaller, single-use reactors running in parallel—rather than one larger vessel—to maintain consistent production conditions and adapt quickly to changes in demand or project success.
Hansen said that this method allows manufacturers to avoid the risks associated with scaling up into large stainless-steel equipment too early: “By having similar equipment, the CDMO can minimize validation requirements for individual equipment units, while building in more flexibility around final manufacturing scale.” He explained that AGC Biologics’ proprietary 6Pack System enables up to six 2,000-liter single-use bioreactors to be operated together or separately for batch sizes ranging from 2,000 to 12,000 liters.
The article highlights how this strategy supports easier process transfer between global sites—including Copenhagen, Chiba, Seattle and a new facility opening soon in Yokohama—and helps manage supply chain risks through standardized procedures. Hansen shared a case study where a project was started at one site due to urgent timelines and later moved closer to the developer partner’s location thanks to shared infrastructure: “This work was enabled by shared infrastructure, a global supply chain and standardized processes and methods for producing the molecule in single-use platforms.”
According to Hansen, adopting a scale-out strategy early can streamline regulatory approval timelines because it reuses established process knowledge rather than requiring new studies each time production increases. He also noted that advanced technologies such as perfusion—where fresh medium is continuously exchanged—can further increase yields even with complex molecules: “Perfusion or N-1 perfusion can also be combined with traditional fed-batch process as an intensification of the seed train to reach higher cell density before inoculating production,” he said.
As demand grows for faster development cycles and capital efficiency in biologic manufacturing, AGC Biologics emphasized that these modular approaches allow companies—especially small- or mid-sized biotech firms—to better match output with market needs while reducing financial risk.
