Infrastructure
Total Area
Total area: ~30,000 sft across Dev Labs, GMP Suites, QC, and Fill-Finish.
Total Area
Total area: ~30,000 sft across Dev Labs, GMP Suites, QC, and Fill-Finish.
Cleanrooms
Cleanrooms: Grade B/A for critical operations, supporting Grade C/D corridors and prep rooms.
Cleanrooms
Cleanrooms: Grade B/A for critical operations, supporting Grade C/D corridors and prep rooms.
Biosafety
Biosafety: BSL-2 across vector and cell suites; segregated unidirectional flows (personnel/material).
Biosafety
Biosafety: BSL-2 across vector and cell suites; segregated unidirectional flows (personnel/material).
Utilities
Utilities: RODI/WFI (loop), clean steam (CIP/SIP?), nitrogen, CO₂, compressed air; validated HVAC with BMS; continuous EMS for temp/RH/DP.
Utilities
Utilities: RODI/WFI (loop), clean steam (CIP/SIP?), nitrogen, CO₂, compressed air; validated HVAC with BMS; continuous EMS for temp/RH/DP.
Cold Chain
Cold Chain: 2–8 °C, –20 °C, –80 °C banks; LN₂ for cell therapy; mapped & alarmed.
Cold Chain
Cold Chain: 2–8 °C, –20 °C, –80 °C banks; LN₂ for cell therapy; mapped & alarmed.
Digital Stack
Digital Stack: LIMS (sample → result traceability), eQMS (deviations / CAPA / change), eBMR / eBR (phase-appropriate), CFR 21 Part 11–ready systems.
Digital Stack
Digital Stack: LIMS (sample → result traceability), eQMS (deviations / CAPA / change), eBMR / eBR (phase-appropriate), CFR 21 Part 11–ready systems.
Let’s Build the Future of Advanced Therapies, Together.
Let’s Build the Future of Advanced Therapies, Together.
Let’s Build the Future of Advanced Therapies, Together.
Let’s Build the Future of Advanced Therapies, Together.
Copyright © 2025 Nucelion All rights reserved.
Copyright © 2025 Nucelion All rights reserved.
Copyright © 2025 Nucelion All rights reserved.