As biologics and cell and gene therapies continue to advance, manufacturing infrastructure is emerging as a critical determinant of speed, scalability, and market access. Traditional facility construction timelines often struggle to keep pace with scientific innovation, prompting organizations to explore more agile alternatives.

During BIO International Convention 2026 in San Diego, BioSpectrum Asia spoke with Brandon Rosendahl of Germfree Laboratories about the growing role of modular and mobile manufacturing environments, the rise of decentralised production models, and how companies can accelerate facility deployment while maintaining stringent regulatory compliance. He explains why infrastructure flexibility may become one of the industry’s most important competitive advantages in the decade ahead.

Modular infrastructure is fundamentally changing the sequence of facility planning, not just the construction method. In a traditional build, process design, architecture and engineering, construction, and commissioning happen in series, which means equipment cannot be validated until the building exists around it. With a modular approach, those workstreams decouple. While a site team handles civil work, permitting, and utility tie-ins, fabrication, fit-out, and factory testing of the cleanroom modules can happen simultaneously in a controlled manufacturing environment. That parallel execution is what compresses a typical 18-to-36-month conventional build into a year or less.

Because a modular cGMP suite can be specified, quoted, and fabricated against a known, fixed-price scope, leadership can commit to capacity decisions with real cost and schedule certainty rather than carrying the open-ended risk of a ground-up build. We’re seeing facility planning shift from “where do we build and how long will it take” to “what configuration do we need, how quickly can it be operational, and what happens if our pipeline changes.” It’s a more dynamic, less permanent way of thinking about capacity – one that lets organizations move at the same speed as the science.

The headline advantage is speed, but the deeper advantage is risk reduction across the entire lifecycle.

On timeline, a factory-built mobile or modular cleanroom is typically operational within 6 to 12 months from order versus 2 to 4 years for a conventional build. Fabrication happens off-site in controlled conditions, in parallel with site readiness, and quality is verified through factory acceptance testing before the unit ships.

Beyond timeline, there are four advantages that consistently drive the decision:

• First, budget certainty. Modular projects are generally quoted and contracted at a fixed price, which removes the change-order risk that tends to accumulate in traditional construction.
• Second is quality consistency. Because modular infrastructure is built in a repeatable manufacturing process rather than by a different trade crew on every job site, materials and finish quality are more predictable, which translates directly into easier validation.
• Third is flexibility. Mobile and modular solutions are assets, not just buildings. An ISO 7 cleanroom or a mobile BSL-2/BSL-3 lab can be relocated, resold, or reconfigured as a company’s pipeline or geographic footprint evolves. A fixed structure cannot.
• And fourth, for organizations with constrained sites, a mobile or modular unit can typically be installed and connected to utilities with far less disruption to ongoing operations than a traditional addition or renovation.

Onshoring is one of the strongest tailwinds in both biopharma and cell and gene therapy right now. The COVID-19 pandemic exposed how fragile a globally distributed supply chain for critical medicines really is, and that lesson hasn’t faded. Governments across North America, Europe, and increasingly Asia-Pacific are backing that concern with real policy: incentive programs, grants, and procurement preferences aimed at building domestic manufacturing capacity for vaccines, biologics, and advanced therapies.

The challenge is that “build domestic capacity” and “do it quickly” are often in direct tension when a conventional facility build takes several years. Modular and mobile infrastructure has stepped into that gap. Organizations that need to establish in-country cGMP manufacturing on a policy-driven or contractually driven timeline now have a realistic path to do it in months rather than years, without committing the full capital cost of a permanent facility to a program that may still evolve. That same dynamic is playing out internationally. Foreign governments and institutions increasingly want sovereign manufacturing capability for biologics or cell therapy, and the economics and timelines of conventional construction make that a difficult case to justify.

For cell and gene therapy specifically, decentralized manufacturing isn’t just a future trend, it’s a clinical necessity. Autologous CAR-T and other patient-specific therapies are constrained by vein-to-vein time: a patient’s cells have to be collected, manufactured into product, and returned to that same patient, often while they’re seriously ill. Every additional step between a centralized manufacturing site and the patient adds time, cost, chain-of-custody risk, and ultimately clinical risk. Locating GMP-compliant manufacturing closer to the point of care meaningfully shortens that loop.

The barrier has always been that building a fully compliant cleanroom suite inside or adjacent to every hospital or treatment center that needs one is impractical under a conventional construction model. Modular infrastructure changes that equation by enabling a network of standardized, pre-validated manufacturing nodes across multiple clinical sites rather than forcing all volume through one central facility. Because each node is built to the same validated design, you also get a more consistent answer to the regulatory and quality question – comparable performance and compliance at every site in the network. This model will likely expand from CAR-T into other autologous and point-of-care therapies, and into emerging markets where the demand exists.

Speed and compliance aren’t in conflict if the approach is engineered for both from the start. The mistake is treating compliance as something to address at the end of a build rather than something designed in from the beginning.

The approach that holds up best in practice starts with designing to recognized global standards from the first layout drawing, so nothing requires retrofitting later to meet a standard it wasn’t originally designed against. Factory acceptance testing and qualification documentation should be generated in parallel with fabrication, not after delivery. That way an organization arrives on-site with most of its validation package substantially complete and only operational and performance qualification remaining once utilities are connected. When a standardized design is replicated across multiple sites, those qualification protocols become reusable too, which compounds the time and cost savings at scale.

The other factor that separates organizations that move quickly from those that don’t is when they bring regulatory and quality expertise into the facility design conversation. Teams that engage their QA function early, mapping facility design to their specific submission or audit requirements before anything is built, rarely face the documentation gaps that surface when compliance is treated as an afterthought. The vendors and partners worth working with treat that conversation as part of the scope, not a separate engagement.

Source: https://biospectrumasia.com/influencers/125/27857/rethinking-biomanufacturing-how-modular-infrastructure-is-accelerating-the-future-of-advanced-therapies.html 

During the facility design phase of a new cleanroom project, one of the most critical steps is defining facility flow. This is how personnel and materials will enter, move through, and exit critical spaces. The US FDA, EMA, and other regulatory bodies provide guidance to reduce contamination risk, but they generally do not prescribe a facility layout that fits every application.

Depending on the product type and target market, there may be expectations for segregation of personnel, material, and waste streams within a holistic contamination control strategy. This is especially true for airflow, where the movement of air through a facility is both a reflection of and a driving force behind the broader personnel and material flow strategy; in higher-classification environments such as aseptic fill-finish suites, unidirectional airflow patterns are deliberately engineered to mirror and reinforce one-way movement.

Unidirectional flow is a facility design strategy in which staff and materials move through the cleanroom in a single direction. This design helps prevent finished product from crossing paths with anything that risks contaminating it, including raw materials, waste, kitting areas, or locker rooms. Layouts that follow this approach often include dedicated supply and return corridors, separate entry and exit airlocks, and a progressive transition through cleanliness zones into and out of critical areas.

Your airflow design strategy should be selected based on the criticality of the operation and the contamination control strategy. For Grade A/ISO Class 5 critical zones where product or sterile components are exposed, unidirectional airflow (UDAF, often referred to as “laminar”) is typically expected and airflow visualization studies should demonstrate first-air protection and effective sweep-away behavior. Surrounding background areas (e.g. Grade B/C, as applicable) commonly used HEPA-filtered mixed (uni-directional) airflow with appropriate recovery, pressure differentials, and verified airflow patterns to support the overall environmental control strategy.

Unidirectional flow eliminates the dual use of airlocks and will often employ certain design features to minimize risk of personnel procedure errors. One useful approach includes magnetic or electrical interlocks to prevent two airlock doors from opening at the same time. That typically avoids use of Wave-To-Open devices on both sides of the door to prevent any personnel from moving back through the entry side.

When designing for unidirectional flow, it’s essential that your personnel and material entry and exit points are fully integrated into the overall facility layout. Kitting and staging areas should align closely with supply corridors, while material exit points should be positioned near cGMP biostorage, filling suites, or clean shipping areas.

Bidirectional flow facilities rely more heavily on HVAC design and air pressure relationships to compensate for the shared movement of personnel and materials through common pathways. Rather than physically separating clean and dirty streams, the airflow strategy recreate this. This typically means steeper pressure differentials between adjacent spaces, higher air change rates within cleanroom and airlocks, and careful attention to the direction of air at doorways and transitions.

In bidirectional designs, passthroughs, whether wall-mounted or floor-cart-based, are a common way to reduce how often doors are opened between zones of different cleanliness classifications, which in turn reduces disruptions to the pressure cascade. Similarly, the shift toward closed RABS or isolators in these environments is partly an airflow decision: these systems create a local unidirectional or contained air environment around the critical zone, reducing dependence on the room-level HVAC.

Lines of demarcation through gowning and support spaces also serve as a behavioural reinforcement of what the airflow design is already trying to achieve.

Throughput has a direct bearing on how hard an airflow system has to work and, by extension, which design approach is appropriate. At lower production volumes, such as those seen in hospital pharmacies or early-stage clinical manufacturing, the frequency of door openings, personnel entries, and material transfers is low enough that pressure cascades and air change rates can recover between disturbances. Bidirectional flow is more viable in these contexts because the HVAC system is not being continuously challenged.

At higher throughput, seen in late-stage clinical or commercial scale manufacturing or in multiproduct facilities, the cumulative disruption to airflow from increased activity becomes a meaningful risk. Unidirectional personnel and material flow reduces the number of times cleanroom air boundaries are crossed, allowing the pressure relationships between spaces to remain more stable. It also simplifies the airflow visualization and qualification picture: when movement through a space is predictable and one-directional, smoke studies and airflow pattern tests are easier to execute and interpret against a defined worst-case scenario.

Facilities designed with future scalability in mind should account for this in the HVAC infrastructure from the outset. An early-phase facility built with appropriately sized air handling capacity, return air pathways, and modular ductwork can accommodate the transition to unidirectional flow (and the more demanding airflow requirements that come with it) without requiring a full redesign.

Personnel movement is one of the leading causes of contamination in the cleanroom, either through the exercise of donning and doffing PPE, gowning errors, or even poor movement in critical spaces. While certain engineering controls can be integrated into the facility to minimize contamination (strategic low wall return locations, increased Air Change Rates, or timed interlock doors), technicians in the space should follow validated standard operating procedures to ensure compliance.

Understanding the risk and level of particulate generation during manufacturing/ compounding will help guide your SOPs. It is necessary to design in accommodations for laminar vertical airflow in ISO 5/Grade A or cleaner environments. This is typically accomplished by having ceiling-mounted HEPA filters with low-wall return/exhaust grilles to pull air from the ceiling down to the floor. This will cause first-pass filtered air to pass cleanly and uniformly over any workstations and processing steps before being removed from the space.

It is important that process equipment, such as Biological Safety Cabinets, refrigerators, workstations, etc., do not interfere with this vertical laminar flow by creating “turbulent” airflow. This happens when airflow builds up, gathers potential contaminants, and keeps them in the cleanroom instead of exhausting them out of the space. Checking for sources of turbulent airflow should be tested during the Environmental Performance Qualification, when static and dynamic smoke tests are performed to visualize the behavior of air through the cleanroom. Validation and commissioning technicians should mimic actual process steps while performing these smoke studies to verify that the cleanroom conditions will be maintained.

Featured in Cleanroom Technology June 2026: https://flickread.com/edition/html/6a326bb8d4ee3#29

Carol Houts takes the helm at Germfree at a moment when advanced therapies are forcing the pharmaceutical industry to rethink how, where, and how quickly medicines are made.

The company, which designs and manufactures modular cleanrooms, isolators, and specialized equipment for pharmaceutical and advanced therapy developers, has long positioned itself around speed, flexibility, and regulatory readiness. Houts describes Germfree’s role as helping customers “move from bench to patient” by giving them the controlled environments needed to stand up GMP manufacturing space faster and with less capital risk than traditional facility builds allow.

That proposition is becoming increasingly important as cell and gene therapies move from scientific promise into clinical and commercial reality. “In advanced therapies especially, where manufacturing processes are still evolving and speed to clinic matters enormously, that agility is a genuine competitive advantage for our customers,” Houts says.

But for Houts, appointed CEO after nearly a decade as Germfree’s Chief Commercial and Strategy Officer, the next phase is not only about innovation. “Germfree has built a strong reputation around disruptive innovation, and that will always be central to who we are,” she says. “But as I step into this role, the focus is on scale and a relentless commitment to delivering for our customers, our team, and the business.”

In this interview, Houts discusses the infrastructure gap facing advanced therapies, why modular manufacturing is becoming a risk-management strategy as much as a construction model, and what it will take to scale manufacturing capacity as the next generation of medicines moves closer to patients.

The science has genuinely outpaced the infrastructure. We’re seeing remarkable therapeutic innovation in cell and gene therapies that, theoretical a decade ago, are now in the clinic – but the manufacturing and facility side hasn’t kept pace. Companies are trying to scale processes that were designed for research, not production, and doing it under enormous time and cost pressure.

A few things stand out. First, speed to clinic is increasingly a competitive and commercial imperative, and traditional facility development timelines simply don’t fit. Second, manufacturing flexibility matters enormously when processes are still evolving, locking into fixed infrastructure too early is a real risk. Third, the talent and workforce required to build and operate these environments is genuinely scarce.

The regulatory environment adds another layer of complexity. Standards are evolving in real time, and developers are making major capital commitments without full visibility into where compliance requirements will land. That uncertainty makes flexibility not just operationally valuable – it’s a risk management strategy.

And internationally, the dynamic is fascinating. There’s significant investment in advanced therapy capability across the Middle East, Asia, and emerging markets – governments and health systems that want sovereign manufacturing capacity, not just access to imported therapies. The infrastructure challenge there is even more acute, because the ecosystem of contractors, tradespeople, and technical expertise that exists in the US and Europe simply doesn’t exist in the same way.

Modular and decentralized manufacturing have moved well past concept – we’re seeing real adoption, and the use cases are maturing. But I think it’s worth being precise about where these approaches create the most value, because “modular” can mean a lot of things.

Where it makes the clearest impact is at the intersection of speed, flexibility, and capital efficiency. For an advanced therapy developer who needs GMP-compliant space in 12 months, not 36, modular is often the only viable path. For a company whose process is still evolving, the ability to reconfigure or redeploy a facility is genuinely strategic. And for organizations working across multiple sites or geographies, modular enables a consistency of environment and compliance standard that’s very difficult to achieve with traditional construction.

But I think the underappreciated story is how modular fundamentally derisks the manufacturing investment. Traditional facility builds require enormous capital commitment upfront, often before a therapy has cleared key clinical milestones. If the program fails and in this industry, programs do fail – that capital is largely stranded. Modular changes that equation. You can right-size the investment to the stage of the program, preserve optionality as your science evolves, and in many cases redeploy the infrastructure if priorities shift. For investors and CFOs evaluating where to put capital, that’s not a minor consideration. It’s often the deciding factor.

On the decentralized side, I think we’re at an early but important inflection point. Point-of-care manufacturing for autologous therapies where the product is made close to the patient is a compelling model scientifically, but operationally it’s enormously complex. The facilities, the logistics, the quality systems all have to work in concert. That’s a hard problem, and it’s one where purpose-built modular infrastructure has a real role to play.

What I’d watch over the next several years is the convergence of modular construction with increasingly automated manufacturing processes. As automation matures, the case for decentralized production becomes much stronger – you can maintain quality consistency without the same dependence on highly specialized local labor. That’s where I think the space is heading, and it’s where Germfree is focused.

Read the full interview with Carol Houts at themedicinemaker.com.

Cell and gene therapies (CGTs) are advancing faster than the facilities that manufacture them. As developers move from early clinical work towards commercial reality, modular, mobile and closed-system infrastructure is becoming central to manufacturing speed, regulatory readiness, and patient access. Both regulators and developers are making strides to bring these life-changing therapies to the patients that need them most.¹

As of early 2026, thousands of advanced therapy medicinal product (ATMP) candidates were in development globally across oncology, autoimmune disease, rare genetic disorders, and other therapeutic areas. Within that landscape, genetically modified cell therapies such as CAR-T remain one of the most active areas of clinical development. ²⸍³ Nonetheless, the infrastructure required to translate these therapies into accessible and scalable treatments remains a major bottleneck. Facilities take time to build, must adapt as processes mature, and need to reflect the practical realities of ATMP manufacturing from the outset.

Cell therapies require a different infrastructure mindset because they are not conventional biologics. They are living, and in many cases, patient-derived products produced in small batches under time pressure to treat rapidly progressing disease. In this environment, manufacturing conditions are not just a backdrop to the science; they are a direct determinant of product quality, release timing, and patient outcome. The gene-modified cell therapy field broadly divides into two manufacturing paradigms—autologous and allogeneic therapies, shown in Figure 1 below.

Autologous therapies use a patient’s own cells, which are collected, shipped to a manufacturing site, genetically modified, expanded, and then returned for infusion. This model introduces a time-sensitive chain of custody in which manufacturing delays can have direct clinical consequences. In CAR-T therapy, the “vein-to-vein” interval from leukapheresis to reinfusion has historically been measured in weeks, and efforts to compress that timeline are now central to process design, manufacturing strategy, and arguably even therapeutic effectiveness.⁴ For autologous products, the challenge is to scale-out, not to scale-up: repeating a precise validated process across multiple suites, shifts, or sites without introducing variability. 

Allogeneic therapies follow a different commercial logic. They rely on healthy donor-derived starting material and aim to create off-the-shelf products that can reach broader patient populations, often using manufacturing models that more closely resemble conventional biopharmaceutical production. Even so, they still require stringent aseptic control, reliable segregation strategies, and infrastructure that can adapt as products move toward commercial manufacturing. 

A defining challenge in ATMP facility design is the need to reconcile product protection with personnel and environmental protection. cGMP cleanrooms are designed primarily to protect the product by minimizing particulate and microbial ingress. EU GMP Annex 1, reinforced by ISO cleanroom principles, emphasizes contamination control strategies, environmental classification, and the use of technologies such as barrier systems and closed processing where appropriate.⁵ In many cleanroom designs, airflow cascades outward from the most critical classified zones to adjacent lower-classification areas in order to protect the process.

Biosafety containment often drives the opposite pressure philosophy. Viral vectors and genetically modified materials used in cell therapy manufacturing can require BSL-2+ or equivalent containment measures intended to protect operators and the surrounding environment. In these settings, inward airflow and suite containment may be needed so that potentially hazardous materials do not escape controlled spaces. Multi-product facilities add a third requirement: cross-contamination control between adjacent manufacturing operations.

ATMP facilities therefore often rely on risk-based hybrid solutions such as sink anterooms, independently controlled HVAC zones, dedicated air handling for production suites, pressure segregation, and carefully designed material and personnel flows. The underlying design question is consistent: how can a facility contain the process without compromising aseptic assurance? In January 2026, the FDA announced greater flexibility in requirements for cell and gene therapies, signaling a more tailored approach to these manufacturing realities. ¹⸍⁶

Traditional biopharmaceutical facilities are often built as fixed, long-horizon assets. Cell and gene therapy introduces a different reality: compressed clinical timelines, evolving process platforms, uncertain scale assumptions, and a constant need to preserve optionality. Under those conditions, infrastructure speed and flexibility become strategic capabilities rather than secondary operational concerns.

Conventional cGMP cleanroom construction at meaningful scale typically takes 18 to 30 months. At current industry benchmarks, full-system biopharmaceutical cleanroom build costs include HVAC, building management systems, environmental monitoring, process utilities, electrical infrastructure, and commissioning, qualification and validation (CQV) depending on scope and location. Modular construction at this scale does not necessarily reduce headline unit cost, but it does improve schedule, predictability, and quality risk. By moving cleanroom fabrication into a controlled factory environment, modular construction allows cleanroom production to proceed in parallel with site preparation and shell work, while factory acceptance testing reduces on-site CQV burden.⁷

Mobile cGMP infrastructure extends the same logic further. Trailer-based and transportable cleanrooms can be deployed directly to clinical sites and operated as point-of-care or near-patient manufacturing capacity. In one deployment at a US academic cancer center, a mobile cGMP suite enabled point-of-care viral vector manufacturing for a hospital client whose existing facility had neither the floor area nor the segregation infrastructure required to support dedicated viral vector production in-house. The platform created compliant segregated capacity that the institution could not readily build into its legacy footprint, while supporting development of the center’s in-house CAR-T pipeline. For autologous therapies, distributed manufacturing closer to the patient is no longer theoretical.

Modular and mobile platforms do not typically beat stick-built facilities on headline per-square-foot cost; the economics emerge through schedule compression, parallel execution, factory-controlled quality, and operational flexibility. On the contrary, transport logistics, ceiling height, utility tie-ins, and site access can constrain certain modular and mobile configurations. In practice, the decision often comes down to how heavily speed-to-clinic, quality certainty, and patient proximity weigh against initial unit-cost. For many CGT programs, the first factors increasingly dominate.

Whatever the physical format of the facility, the process architecture inside it increasingly revolves around closed systems. Because cell therapy products cannot be terminally sterilized or filtered, contamination control during manufacture is essential. Closed processing reduces operator intervention, limits environmental exposure, and can in some cases support operation in lower-classified surrounding cleanroom environments when justified through a sound contamination control strategy.⁵ Lower surrounding classifications can reduce HVAC demand, gowning burden, cleaning intensity, and environmental monitoring requirements. The benefit is not only simplicity and reduced cost, but also a shift away from broad room-based controls into tightly engineered process containment. Isolator technology can be particularly favorable where closed processing is not possible and a higher-classification cleanroom is not feasible.

Automation is a natural extension of that trend. In manual cell therapy workflows, operator-dependent variability remains a common source of deviation. Automated or semi-automated closed systems can improve reproducibility, standardize execution across sites, and generate the process data needed for more advanced control strategies. Automation is not universally the right answer, however; it requires greater upfront capital and may reduce flexibility in early stages of process development.

One of the most persistent infrastructure mistakes in CGT is designing too narrowly around the present moment. Research-oriented spaces that work in early development can become liabilities when a product moves toward pivotal studies or commercial launch. Qualification strategies deferred too late can create downstream delays, and environmental monitoring programs may be difficult to justify during regulatory review if they were not designed with eventual cGMP expectations in mind. 

Planning with commercial intent does not mean overbuilding from day one. It means making early facility decisions that preserve future pathways, including layouts that support likely process flows, utility and HVAC strategies that can accommodate expansion, and CQV planning aligned with the product’s development arc. Facility decisions echo through tech transfer, comparability, regulatory submissions, batch records, operator training, and supply reliability. 

Infrastructure choices undoubtedly influence patient access. Autologous CAR-T therapies can exceed $500,000 per patient when total cost of care is considered, and manufacturing complexity is one contributor to that burden.⁸ The cost and geography of production affect where therapies can be offered and how far patients and materials need to travel.

Better infrastructure alone will not solve access, but it is part of the solution. Modular construction can reduce timelines, closed and automated systems can improve consistency, and point-of-care or near-patient manufacturing can reduce logistics friction in autologous workflows. These are not just engineering choices; they are commercial and patient-access decisions embedded in the built environment.

The science of cell therapy has advanced rapidly, and the infrastructure supporting it is evolving in parallel. In cell therapy, infrastructure is part of the platform. The facilities that succeed will be those designed not only to meet current requirements, but to absorb process change, support regulatory compliance, and enable therapies to reach patients more efficiently.

European Biopharmaceutical Review, Summer 2026, pages 46-48. © Samedan Ltd.

1. Visit: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/flexible-requirements-cell-and-gene-therapies-advance-innovation
2. Visit: https://www.asgct.org/uploads/files/general/Landscape-Report-2026-Q1.pdf
3. Visit: https://www.isctglobal.org/publications/regulatory-quality-initiatives/global-regulatory-report/global-regulatory-report-2025
4. Visit: https://www.ashpublications.org/bloodadvances/article/9/11/2663/535370/Impact-of-vein-to-vein-time-in-patients-with-R-R
5. Visit: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
6. Visit: https://www.fda.gov/news-events/press-announcements/fda-increases-flexibility-requirements-cell-and-gene-therapies-advance-innovation
7. Visit: https://www.deloitte.com/us/en/services/consulting/articles/greenfield-manufacturing.html
8. Visit: https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/car-t-cell.html