Flexible, Agile, Scalable, Infrastructure
FAST GMP™
FAST GMP™
The stick-built GMP facility is the single largest source of cost and delay in bringing a medicine to patients. FAST GMP™ re-engineers the physical plant as modular, reconfigurable cleanroom pods inside flexible shell space. Built with modular building blocks, deployed in months, reconfigured without demolition. See more information at our Resource Center.
Status: Engineering is underway with our engineering partner. The first units are scheduled to be in place in early 2027.
FAST GMP™ pod, two-airlock base configuration, installed inside existing lab space. Illustrative rendering.
>3X
Faster facility lead time vs. a traditional build
<1/3
Lower initial build cost than a stick-built equivalent, scoped to the same classification and room count
From order to operational, versus 18 to 24 months
3 to 6 mo.
Figures are design targets based on our engineering model and the projects we have quoted. They are not yet independently validated.THE PROBLEM
The building is the bottleneck.
A traditional cleanroom takes 18 to 24 months to build and validate, locks capital into concrete, and cannot be reconfigured when the science changes. That model was built for blockbusters and is exceedingly expensive. It does not fit personalized, distributed, or rare-disease manufacturing, where speed and flexibility decide whether a patient is treated in time.
WHAT IT COSTS
The cost structure has inverted.
A traditional stick-built suite locks millions into concrete before a single batch runs. Across the projects we have quoted, a small multi-cleanroom facility estimated at ~$10M stick-built comes in between $1 and $2M as FAST GMP™ equivalent space, installed. The equipment inside a modern suite now costs more than the suite that houses it.
TRADITIONAL STICK-BUILT: SMALL MULTI-CLEANROOM FACILITY
~$10M
Figures are design targets based on our engineering model and the projects we have quoted.
FAST GMP™ EQUIVALENT SPACE
$1 to $2M installed
Same classification and room count. A reduction of more than 70 percent. 3 to 6 months from order to operational.
What the quoted figure covers: the pod and standard installation, assuming electrical service has been run to the location and exhaust connections are ready to be made.
Scoped separately after a site survey: new electrical service, floor preparation and coating, exhaust tie-in to an out-of-building line, freight and rigging, commissioning and qualification labor, process equipment, controls and monitoring integration, fire suppression if required, and seismic or local code compliance.
THE ARCHITECTURE
Floorless anchoring
Pods install directly onto an existing floor. No demolition, no poured foundation, no facility downtime.
Dry-seal cam-locks
Non-progressive dry-seal joints replace silicone. That eliminates outgassing and chemical degradation, and lets a pod be reconfigured or moved cleanly.
Engineered for speed, built for change.
HVAC backpacks
Decentralized HVAC control reacts instantly when a door opens, holding pressure and cleanliness per pod rather than across a whole building.
Single-panel swap-out
A hazardous or radioactive spill means swapping one panel, not condemning a facility. A radiation-shielded panel variant supports high-activity isotope work.
Designed to meet US cGMP, EU Annex 1, and global requirements.
A target validation window of 2 to 4 weeks after installation. Compliance is established through qualification and validation at each installation.
A GMP suite has a service life measured in decades. The pod is designed so that maintaining it, moving it, and reconfiguring it are routine operations rather than capital projects.
Built as infrastructure, not a one-time purchase.
Owning a pod
Service and spares
Pods are serviced on a scheduled interval. Panels, gaskets, and HVAC modules are stocked replaceable items, not custom fabrications.
Warranty and support
Each unit ships under warranty with defined response times. Support covers the pod envelope, the environmental control module, and the monitoring interface.
Built to be moved
A pod is not a one-time build. Reconfigure the layout, relocate the suite, or repurpose it for a different modality without demolition.
Standard, replicable pod designs make distributed manufacturing real. Put capacity next to the patient, aggregate fragmented rare-disease and N-of-1 demand into shared FAST GMP™ capacity, and keep every suite productive. Deploy a suite close to the point of care. Each setting carries its own regulatory pathway, and we scope that pathway with you before anything is built.
One design, deployed anywhere.
WHY IT MATTERS
Put a GMP suite where you need it, in months, not years.
Tell us about your program. We will tell you how to build for it.