Facility & Clean-Room Design
Personnel and material flows, gowning, airlocks, controlled suites, pressure cascades, HVAC, HEPA filtration and environmental monitoring.
ADVANCED BIOLOGICAL PRODUCTION
Stem Cell & Exosome Production Facilities
Purpose-designed controlled environments for cell processing, conditioned media handling, exosome isolation, purification, formulation and quality control.
Request a feasibility study ↗VISION ADVANCED BIOPROCESS PLATFORMCulture · isolation · purification · characterization · fill & finish
Closed processContamination-controlled workflow
ScalableResearch to production scale
CharacterizedIdentity, purity and potency strategy
TurnkeyPlant, process and training
TURNKEY PROJECT MODEL
From facility concept to operational transfer.
Infinity IVD coordinates architectural planning, clean-room engineering, process equipment, utilities, qualification, documentation and personnel training around the intended research or manufacturing scope.
Cell Processing Infrastructure
Biosafety cabinets, CO₂ incubators, centrifugation, cell counting, microscopy, controlled-rate freezing and cryogenic storage.
Exosome Isolation & Purification
Clarification, filtration, tangential-flow filtration, ultracentrifugation or chromatography workflows selected for scale and purity.
Formulation, Filling & Storage
Controlled formulation, aseptic handling, filling, labeling, cold storage and qualified frozen-storage solutions.
Quality Control Laboratory
Identity, particle size and concentration, sterility, mycoplasma, endotoxin, viability, protein markers and release testing.
Utilities & Support Systems
Required water systems, process gases, clean compressed air, cold chain, backup power and monitored storage.
Qualification & Documentation
URS, DQ, IQ/OQ, SOP framework, batch records, maintenance and calibration plans.
Technology Transfer & Training
Process mapping, equipment operation, contamination control, QC methods, trial batches and operational handover.
CORE PRODUCTION SYSTEMS
A complete advanced-therapy manufacturing ecosystem.
Equipment is configured around the selected cell source, culture format, batch scale, isolation strategy, final presentation and applicable quality pathway.
Class II biosafety cabinets
Closed cell-processing workstations
CO₂ incubators and cell factories
Single-use bioreactor systems
Refrigerated centrifuges
Tangential-flow filtration skids
Chromatography and ultrafiltration
Particle analysis and flow cytometry
Automated aseptic vial filling
Controlled-rate freezers
−80°C and cryogenic storage
Environmental monitoring
QUALITY CONTROL STRATEGY
Evidence from starting material to final preparation.
The final panel is selected for product type and intended use. A representative program may include:
Cell identity & viabilitySterilityMycoplasmaEndotoxinParticle size & countSurface markersResidual impuritiesPotency strategyContainer integrityStability
REPRESENTATIVE PROCESS
Controlled from source to final preparation.
01Cell source & qualification02Expansion & conditioning03Harvest & clarification04Isolation & purification05Characterization & QC06Formulation & storage
The exact process, biosafety level, clean-room classification and release criteria depend on intended use and applicable national requirements.
Plan an exosome facility ↗