From design through verification
We deliver turnkey scope covering cleanroom panels, ceilings and doors, flooring, HVAC and constant temperature and humidity units, HEPA filters and FFU, differential pressure design and monitoring, electrical, lighting and fire protection, piping, pass boxes and air showers — continuing through IQ, OQ and PQ validation and performance verification certificates.
These are the same standards OCELLBIO established while designing its own fourth-floor facility.
Sized to the site
Not every clinic needs a large facility. A compact clean booth suits sites focused on cryogenic storage and thaw-and-administer preparation, while a cleanroom suite suits sites that also process specimens and run quality testing.
Because the required licensing level depends on the scope of work performed, we help define the business scope before finalizing equipment specifications.
Protecting the legal status of the facility
A facility for storing and releasing sealed cells and a facility that processes cells directly require entirely different licenses and equipment levels. OCELLBIO designs only the grade actually needed for the work the client will perform, reducing both over-investment and regulatory risk.
This website is intended to introduce OCELLBIO's business. OCELLBIO Inc. was incorporated in August 2026 and is currently building out its headquarters facility; the facility and equipment specifications shown are design-stage figures and will be finalized during construction and verification. Culture, quality testing and batch release of clinical-grade cells are performed by manufacturing facilities licensed under the applicable regulations, while OCELLBIO is responsible for the storage, logistics and quality documentation of cells handled in sealed condition. Specific terms of cooperation are provided on request.