Designing Pharma Facilities For Change, Not Just Capacity

By Katie Anderson, Chief Editor, Pharmaceutical Online

Pharmaceutical innovation is making drug manufacturing more complex—and placing new demands on facility design. Accommodating today’s processes is no longer enough. Facilities must also be able to change. Modular design offers a way to build that adaptability into the facility itself.

How can a facility accommodate complex pipelines, expand as demand grows, and adapt to different drugs without interrupting current production? That question guided our live panel discussion with Jurgen Wiedemann and Rohit Herve, which explored how modular design can make change and flexibility part of a facility’s underlying architecture.

“The flexibility comes especially by having independent units that can be changed without impacting the others,” explained Wiedemann. Rather than connecting every operation to every other operation, he described a facility made up of smaller, largely independent factories. Harve put the underlying engineering challenge another way: “You can't design for technology you can't see, but you can design for change itself.”

Build Infrastructure Now, Add Capacity Later

For both panelists, flexibility begins with the building’s underlying infrastructure: a central spine carrying utilities, services and standard connection points so future modules can plug into an established framework. The initial investment includes the shell, spine, digital backbone and potentially one qualified suite for the first product. Space and comparatively inexpensive infrastructure can be reserved or oversized, while expensive equipment waits until demand justifies it. “So again, build the bones now and then add capacity later,” reiterated Harve

That does not mean every modular facility should look alike. Wiedemann distinguished a spine-based OSD facility from an API operation, where piping can carry much of the material flow. He also questioned whether combining widely different technologies in one large plant would always make sense. “But as long as technologies fit to each other, it makes sense to have some in the building where you have a spine,” added Wiedemann. The modular principle can remain consistent, even when its physical execution changes.

Harve pointed to biologics as a strong use case, citing the maturity of single-use equipment for antibodies, vaccines, and recombinant proteins. Shared infrastructure, however, is not the same as shared processing space. “You share the building, you share the utilities, you share the services, but then you segregate the production suites and you use closed processing to make sure that you can control cross-contamination,” he added. His organizing principle was explicit. “So, the design principle here is zoned by risk, potency and sterility, not so much by your product label.”

Standardize Interfaces

Making modules work together requires standards on the physical, GMP, and digital sides. Harve outlined fixed module dimensions, standard structural frames and consistent utility connections, alongside defined cleanroom grades, pressure cascades, and a risk-based contamination control strategy. Factory testing can reduce the testing required at the site. Common automation standards, including ISA 88 and ISA 95, also help establish how plant systems connect. “You want to have standards that are fixed,” noted Harve..

Wiedemann emphasized that early design decisions must distinguish central services from decentralized ones and identify where future modules will connect. Those interfaces determine whether a technology or product change stays local or triggers a much broader qualification effort. “What we did is that our spine is a qualification border between the modules and the rest of the facility,” noted Wiedemann.

HVAC and water systems illustrate the stakes. Wiedemann described separating HVAC service for the spine from service for individual modules, rather than allowing one system to span both. Water systems can likewise be separated or designed with a qualification boundary, such as a buffer tank within a module. The aim is to keep changes and requalification contained instead of revisiting a large, integrated system. “That is the lessons learned from old times when you had the highly integrated plants, and it was a nightmare whenever you needed to change something,” commented Wiedemann.

Commercial Readiness

Faster construction does not automatically mean faster commercial readiness. “The runway actually depends on the molecule, not so much the module,” explained Harve. He described a potential 12- to 18-month timeline for module readiness, while noting that a new modality or higher-potency product can take longer. Technology transfer, validation batches, stability data, and the regulatory path still set the pace. “So, basically the smart money goes into the parts of the timeline that faster construction cannot shorten.”

Harve identified standard automation, digital twins for commissioning before a module arrives, and an upfront regulatory change strategy as ways to address those constraints. Modularity can also provide options when demand changes: identical modules can occupy reserved space if demand rises, while suites might be repurposed or leased if it falls. “So sometimes a surprise can become a scheduling decision, not so much a capital crisis,” added Harve.

Copy and Paste Design

When demand exceeds expectations, Wiedemann sees two routes: scale out or scale up. Repeating an existing module can reduce both project time and demands on internal specialists. “You save a lot of time, you save a lot of workforce, and the most valuable workforce in projects is your own people and you only have a limited amount of experts,” explained Wiedemann. A repeatable design allows those experts to move into execution rather than repeat earlier work.

Scaling up within a module is also possible when the building anticipates different equipment sizes. Wiedemann said the standard Solida-1 production facility can accommodate 60, 120, 200 or 250 kg batches by changing the equipment inside while retaining the building layout. “Another possibility is that if you have a module designed smart, basically designing modules is like making Lego blocks,” added Wiedemann. That flexibility has a physical ceiling. Eventually, larger machines require a different building block.

Design For Change

Different layers of a facility age at different speeds. Harve contrasted a structure lasting 30 years or more with utilities and process equipment lasting perhaps 10 to 15 years, and software changing over in two to five years. “So the most expensive mistakes happen when a fast changing layer like software is locked into a slow one,” he explained. His approach is to establish generous ceiling heights, floor loading and column spacing early, leave room in utility routes, and provide zones that can accommodate greater containment. “So the engineering challenge here is to decide what to lock in now and what to leave open.”

For Wiedemann, the uncertainty around future software makes data continuity especially important. Recalling the early planning for Solid-1, he said the team could not predict how artificial intelligence would develop, but recognized a requirement that would endure: “We don't know how the software looks like in four, five, six, seven years, but we know the software needs data.” A data backbone should keep machine and production information accessible as applications change. Physical space matters, too. “And I think it's a nightmare if you could do something and you cannot do it because you simply run out of square meters,” he said.

Higher Potency Changes Containment

When asked how an ADC pipeline changes facility design, Wiedemann noted the need for more detailed engineering and dedicated provisions for handling highly potent materials. “You need to work out things more detailed when you jump into the high potent arena,” he said. Pharmaceutical production focuses on protecting the product from its surroundings, while high-potency processing must also contain the product and API. That changes the pressure strategy and HVAC design. “But if you handle high potents, you want to protect your product, but even with a higher priority, you need to protect the surrounding from your product, from your API.”

The real test of a modular facility is not how well it accommodates today’s process, but how much can change tomorrow without disrupting what already works. Independent suites, defined qualification boundaries, room to expand, and accessible data make that adaptability a design decision rather than a future retrofit. The goal is not to predict the next molecule or technology. It is to keep today’s infrastructure from becoming tomorrow’s constraint. As Harve put it, “So design for interfaces for future, not so much the contents that go into it.”Ca