Stem Cell & Exosome Facility

What the facility produces and why it matters locally

Controlled cell-processing and extracellular-vesicle production configured only after source, intended use and legal pathway are fixed. The investment case is tested against import dependency, procurement demand, supply resilience, attainable local content and regional export access. Portfolio definition precedes equipment selection so capital is not locked into an incompatible process.

Indicative capital band

USD 4.5–14M. The range covers core equipment, controlled environments, process utilities, installation, qualification, technology transfer and initial training at the stated tier. Preliminary engineering range; excludes land, finance cost, taxes and import duty. Final scope and price are confirmed at the feasibility gate.

Footprint and clean environment

1,800–4,500 m² gross; 500–1,500 m² classified processing, typically Grade C/ISO 7 backgrounds with Grade A/ISO 5 critical manipulations where aseptic processing applies.

Critical open aseptic manipulations require ISO 5/Grade A protection with an appropriate Grade B/C background; closed processing may support a lower background after formal contamination-control assessment.

Programme from design basis to operation

18–30 months to qualified facility and pilot process; clinical/product authorisation is separate. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.

Installed capacity tiers

Published only after cell source, batch scale, dose definition, recovery yield and intended use are fixed; a generic units/year figure would be misleading.

Capacity assumes qualified materials, stated shifts, planned maintenance and validated yield; it is not the sum of nominal machine speeds.

Process flow and utilities

Core process

• Qualified cell-bank receipt and quarantine
• Upstream culture and expansion
• Harvest, clarification and concentration
• Tangential-flow filtration, chromatography or ultracentrifugation as selected
• Sterile filling or controlled final packaging
• Identity, purity, potency, sterility and stability testing

Site and utilities

High-reliability HVAC and backup power, clean gases, qualified water where applicable, cryogenic systems, monitored cold chain, bio-waste decontamination and robust electronic traceability.

Regulatory and quality endpoint

GMP or tissue/cell establishment pathway depends on intended use and claims; ISO 14644 qualification and country-specific biological-product or clinical-practice oversight. Typical facility readiness: 15–24 months.

Infinity IVD delivers the contracted facility, QMS, validation and dossier work. Certification or market authorisation is granted only by the competent independent authority.

Staffing and transfer of know-how

Indicative 30–70 specialist FTE; 12–24 weeks training covering aseptic processing, analytical methods, deviation control and supervised engineering batches.

Equipment classes and procurement boundary

• Closed culture systems, incubators and biosafety cabinets
• TFF, chromatography or ultracentrifugation platforms
• Particle characterisation and analytical instruments
• Aseptic filling, cryostorage and monitored cold chain
• Environmental and microbiological monitoring systems

The feasibility equipment register identifies supplied equipment, client-supplied items, spares, initial consumables, FAT/SAT responsibility, calibration and qualification ownership.

Critical process risks and operating economics

• Cell-bank contamination or identity loss
• Batch-to-batch potency variability
• Low recovery during isolation
• Adventitious-agent contamination
• Uncontrolled claims changing the regulatory classification

Operating economics are issued as a sensitivity model using local labour, utilities, materials, yield, utilisation and financing assumptions; they are not a guaranteed return.

Relevant delivery evidence

• Project references disclosed only after intended-use alignment and client authorisation

Client names and photography are disclosed only with permission; confidential programmes retain a technical envelope rather than an invented attribution.

Technical brief and feasibility gate

The investor brief records the published assumptions, process flow, capacity tiers, regulatory route and data required for a binding feasibility package.