Disease outbreaks and innovation in the vaccine sector are increasing demand for flexible modular manufacturing technologies, according to bioindustry experts. Methods used to make therapeutic proteins and monoclonal antibody-based medicines have evolved over the past forty years.
Standardized manufacturing techniques have allowed firms to increase yields and shorten timelines. Likewise, flexible single-use and modular production systems have helped manufacturers reduce costs.
By contrast, vaccine production methods have changed little over the period, according to Robin Shattock, PhD, head of mucosal infection and immunity in the department of medicine at Imperial College London, who pointed out that the economies of scale required are part of the problem. “Many traditional vaccine processes, like formation, viral vectors, recombinant proteins, are based on large-scale production and by their nature are not amenable to modulation,” he explained.
But vaccine makers are beginning to modernize their production methods, continued Shattock, citing the increased availability of single-use technologies as a key facilitator. “The advent of disposable technology is increasing the flexibility to manufacture different [vaccine] products within the same unit.”
Shattock expects the pace of change to accelerate, with innovation in vaccine development necessitating advances in manufacturing technologies and facility design.
“The game changer for modularization is likely to be the development of nucleic acid vaccines that use the same generic process irrespective of the vaccine target,” he said. “These new approaches rely on scaleout—adding additional lines—rather than scaleup and can enable a distributed approach to vaccine manufacturing.”
The idea of a growing vaccine sector demand for modular manufacturing technologies is in keeping with recent comments by officials from GE Healthcare. The company recently partnered with modular facility design specialist Pharmadule Morimatsu to develop modular biomanufacturing platforms that allow “biopharma manufacturers to quickly scale up vaccines, viral vector-based therapies, and other novel modalities,” according to GE Healthcare.
“Modular facilities address the need for rapid deployment and flexible manufacturing capabilities,” a GE Healthcare spokesperson told GEN. “While there are many providers of modular facilities for biopharmaceutical production, distinguishing factors include in-depth knowledge of manufacturing-specific modalities for novel therapies, proven expertise in the space, long-term support capabilities, and project management from one point of contact. This is pointing to our KUBio offering as a solution of choice.”
Vaccine companies that go modular need to think about the cost implications. Most modular tech companies stress the CAPEX benefits of off-the-shelf facilities versus traditional stainless-steel equivalents. Brownsburg, Indiana-based Biologics Modular emphasized the cost benefits of its prefab clean room design in a U.S. patent it received earlier this year.
However, it is important that such savings be carefully assessed, noted Eric Langer, president and managing partner at BioPlan Associates.
“Often it is not the case that modular is cheaper than stick-built facilities,” Langer said, adding that the additional quality, flexibility, and stack-ability provided by modular plants comes at a cost.