Designing multimodal GMP suites
Designing multimodal GMP suites
Considerations for dedicated and campaigned use
Multimodal manufacturing is about to revolutionize our industry. CMOs, under pressure to stay fast and flexible in the competitive biopharma marketplace, have already introduced product-neutral manufacturing in clinical-phase projects. It’s only a matter of time before this approach reshapes manufacturing at the clinical and commercial scale.
As we deepen our understanding of the science behind it, new equipment, technologies, and environmental designs will emerge to support this shift towards multimodal, and our industry’s comfort level will evolve accordingly. It’s a trajectory that we’ve seen with each historic leap forward, moving us gradually from skepticism to cautious acceptance and finally to industry-wide implementation.
This article will nudge our industry a little further along that trajectory. By holding up the familiar example of a multimodal facility with dedicated manufacturing spaces as our benchmark, we will explore the possibility of campaigning between modalities at the suite level. What are the unique considerations in play? How should operators define the risk profile of these product-neutral spaces in order to ensure their efficient, safe, and reliable operation? What challenges will face us as we move towards this manufacturing approach, and what opportunities await? Let’s find out.
This article will examine two types of manufacturing spaces:
1. Dedicated use
In this environment, manufacturing spaces work in tandem to support concurrent production of multiple products within a shared facility. Each manufacturing space is designed for a unique function and is dedicated to a given product platform for the life of the facility.
2. Campaigned use
The spaces inside this facility operate in the same way as those described above, with this critical difference: they’re specifically designed with the flexibility to campaign between product platforms. The idea is that facility operators will decontaminate each suite and swap out equipment following a product campaign, effectively neutralizing the manufacturing space and readying it for a new product platform. A facility designed with several product-agnostic suites creates unparalleled flexibility; think of it as a Gatling gun for a facility’s complex product pipeline.
