The journey of a modern therapeutic from a lab concept to a commercial product is rarely a straightforward process. The manufacturing needs for a Phase 1 safety trial are fundamentally different from those required for a large-scale Phase 3 study or commercial launch. This dynamic reality presents a significant challenge to pharmaceutical and biotech companies: the infrastructure intended to ensure product quality and safety can become a barrier to progress.
Traditionally, companies face two imperfect choices when scaling drug manufacturing: build their own cleanroom facility, an expensive, time-consuming process, or outsource to a contract development manufacturing organisation (CDMO), often sacrificing control, speed, or customisation.
The traditional binary choice between building in-house or outsourcing has become even more limiting as drug development has become more complex, fuelled by the rise of advanced therapy medicinal products (ATMPs) and precision medicines. These therapies often require specialised processes, smaller batch sizes, and faster iteration, needs that don’t align well with static facilities or conventional outsourcing models designed for high-volume, standardised production. As a result, it has become more difficult for companies to keep pace with today’s speed, scale, and regulatory demands.
Driven by these unmet needs, a third path is emerging: adaptive cleanroom environments that are modular, configurable, and operationally ready in weeks, not years. These “next-gen” spaces are giving companies immediate access to GMP infrastructure without long-term commitments or compromises. The idea of this new path is to offer a more agile route to market, helping drug developers keep pace with innovation and unlock a smoother transition from clinic to commercialisation.
The path from concept to commercial product can be seen as a three-act play
Manufacturing's three-act structure: From phase 1 to commercial
The path from concept to commercial product can be seen as a three-act play. Each act represents a distinct phase of clinical development with its own plot points, objectives, and unique demands placed on the production environment. A facility designed for only one act will inevitably struggle when the curtain rises on the next.
Act I: Speed to clinic (phase 1): In this opening act, the guiding principle is pragmatism over perfection. The primary goal is speed, not to create a flawless commercial process, but to generate initial human safety data as efficiently as possible. This requires producing safe small-batch material quickly using processes that are often manual and still being defined. The cleanroom, therefore, must reflect this pragmatic approach. It needs to support rapid setup and basic process execution without the capital expenditure and long-term commitment of building a dedicated facility.
Act II: Process refinement (phase 2): During the second act, the focus shifts. As the trial expands to include more patients, the demand for material increases. The process itself undergoes refinement with an emphasis on improving consistency and incorporating systems that create a physical barrier between the product and the environment to reduce contamination risk. This is where early automation is often introduced. A cleanroom built and capitalised only for Act I will struggle to accommodate the new equipment and changing workflows without costly, time-consuming modifications.
Act III: Scale and efficiency (phase 3 & commercial): In the final act, the process must be robust and scalable – whether scaling up with larger equipment or, as for cell therapies, by scaling out with multiple parallel production lines. The cost of goods becomes a pivotal driver of long-term viability.
Traditional infrastructure often forces companies into costly reinvention at every turn
Each act in the drug development journey brings new technical and operational demands; however, traditional infrastructure often forces companies into costly reinvention at every turn. The real challenge isn’t just the cleanroom itself, but how quickly and seamlessly a company can adapt: securing space, mobilising teams, validating systems, and meeting regulatory requirements.
The transition between phases 1 to 3 can create hidden bottlenecks, including delays in facility readiness, long lead times for validation, or misaligned infrastructure that no longer fits the evolving process. Each delay compounds, stretching timelines and increasing costs, whether it's stalled tech transfer or waiting on compliance signoff. In a development landscape where every month matters, these frictions can become critical vulnerabilities.
To navigate these bottlenecks more effectively, drug developers need to consider approaches that enable faster access to space, adaptable capacity, and infrastructure aligned with each phase.
The blueprint for cleanroom flexibility
For drug developers navigating fast-changing pipelines and the complexity of therapeutic production, as with ATMPs, the ability to adapt manufacturing infrastructure is increasingly critical. However, identifying a truly flexible cleanroom offering goes beyond surface-level claims. It requires looking at how the space is designed, accessed, and supported.
Two key architectural and engineering strategies can help signal whether a cleanroom environment is built with this kind of adaptability in mind:
Modular systems: By leveraging pre-engineered wall and ceiling panels that can be installed quickly with minimal assembly, modular systems offer two key benefits. Firstly, these modular systems enable a suite to be deployed or reconfigured in weeks instead of months, directly accelerating the timeline to get a process up and running. This timeline is accelerated even further because a facility provider handles the complex and lengthy process of initial facility validation, allowing a company to focus solely on its own process-specific qualification. This speed is a decisive advantage when bringing a therapy to the clinic.
Secondly, the approach is highly cost-efficient. The speed, reduced on-site labor, and minimised downtime can lead to lower project costs. The panels can also be disassembled and reused in future layouts, allowing a facility provider to offer customisable spaces when needed and supporting a more sustainable facility lifecycle.
Ballroom floor plan design: A ballroom floor plan design moves away from constructing multiple small, single-purpose suites in favour of a large open-plan cleanroom. Essential infrastructure, such as power, network connectivity, and process gases, is delivered through a grid of overhead utility connections, allowing equipment (often mounted on mobile skids) to be easily arranged and reconfigured. Crucially, this layout enables the formation of flexible, defined zones within a shared space. These zones can be adjusted in size, layout, and function to accommodate different process steps, equipment types, or production scales, without the need for new room construction. A company might begin with a single processing skid for early-phase work, then scale by adding parallel skids in adjacent zones as production needs increase. This zoning capability supports both spatial efficiency and functional adaptability, helping future-proof the environment as product pipelines and technologies evolve.
While design strategies like modular construction and ballroom layouts enable physical flexibility, the broader value lies in how these spaces are accessed and adapted over time. It is important for drug developers to remember that operational flexibility extends beyond walls and floor plans; it includes how quickly a space can be made available, how easily it can be tailored to a process, and how efficiently it scales across different development stages.
Truly flexible cleanroom environments will offer more than just physical reconfigurability. They will also be adaptable in how companies access and use them. This means:
Available for short- or long-term use, depending on the project’s needs
Structured around flexibility, so companies only pay for what they need, when they need it
Designed for choice, allowing companies to use their own teams or select only the services that add value
Scalable without disruption, able to grow or shift as the programme evolves
Operationally ready in weeks, not months, removing the delays of traditional construction or onboarding.
In contrast to traditional models that require long-term commitments or rigid outsourcing frameworks, this approach introduces a more agile infrastructure option that can evolve with the demands of complex, modern therapies.
Closed systems: The room within the room
Modular construction and ballroom layouts create the physical framework for flexible cleanroom facilities. But it’s advances in processing technology, especially the rise of functionally closed systems, that enable this flexibility to be fully realised. By separating the sterile process from the surrounding environment, closed systems reduce the need for high-grade cleanroom classifications. This makes it possible to run different processes side by side, reduce HVAC complexity, cut operational costs, and make better use of available space.
Technologies like gloveless robotic isolators, automated cell processing units, and integrated single-use fluid path assemblies are changing the paradigm of aseptic manufacturing. These systems contain the sterile process internally, effectively protecting the product from the surrounding environment and the operator.
Separation of the process from the room is a transformative development. Because the equipment itself maintains the critical Grade A (ISO5) sterile environment, the surrounding cleanroom's classification can often be lower. A process that once required a Grade B (ISO 7) background may now be safely run in a Grade C (ISO 8) or even Grade D (ISO 9) environment, depending on the risk assessment and product requirements. The strategic impact is enormous. A lower-grade room requires significantly fewer air changes per hour, which dramatically reduces costs associated with energy consumption and the cost of licensing and accessing appropriately classified space.
Customisable cleanrooms: Where therapeutic innovations have the space to transform
Biotech and pharma innovation moves fast, much faster than the traditional facilities built to house it. To truly match the pace of science, companies need access to cleanroom environments that aren’t just flexible in theory, but engineered for adaptability in practice.
The model outlined here represents a strategic shift. It combines modular architecture, ballroom layouts, and closed system technologies into an integrated cleanroom platform, one that scales across clinical phases and adapts in real time to evolving process needs. But this flexibility extends beyond the design of the rooms themselves. It includes how companies engage with cleanrooms: choosing only the space and services they need, setting their own timelines, and retaining control over their manufacturing process without being locked into the constraints of traditional buildouts or outsourcing models.
This is not flexibility for its own sake; it’s flexibility with purpose: accelerating development, lowering risk, and preserving capital. For drug developers, this approach transforms the economics of manufacturing. Instead of locking into rigid infrastructure and unpredictable build timelines, companies can align cleanroom access with the natural rhythm of their pipeline. What was once a major capital investment becomes a controllable operating cost. And what was once a bottleneck becomes a launchpad.