OUR MANUFACTURING SITE
- Our state-of-the-art manufacturing facility is designed to meet the highest standards for the production of advanced cell and gene therapies. the site integrates all critical components required for the development, production, and quality assurance of CAR T-cell therapies and lentiviral vectors.
SITE SECTIONS
PRODUCTION UNITS (CLASS B CLEANROOMS)
CAR T-Cell Production Suite: A GMP-compliant Class B cleanroom dedicated to autologous CAR T-cell manufacturing. This unit supports: T-cell isolation, activation, and transduction, Expansion and formulation, Final fill and cryopreservation
CELL BANK FACILITY
Master and Working Cell Banks: Secure temperature controlled storage of validated cell lines used in vector production and quality control assays, Redundant storage systems (-80°C and liquid nitrogen)
QUALITY CONTROL (QC) LABORATORY
Sterility, endotoxin, and mycoplasma testing, Vector titration and transduction efficiency, Flow cytometry, Environmental monitoring of cleanrooms
QUALITY ASSURANCE (QA) UNIT
Ensures compliance with GMP and national regulatory standards: Batch record review and release, CAPA and deviation management, Supplier qualification and audit readiness, Document control and training systems
STORAGE & LOGISTICS
-80°C freezers and vapor-phase liquid nitrogen tanks, Secure chain-of-custody for patient-specific products
RESEARCH & DEVELOPMENT (R/D) WING
A dedicated space for innovation and pipeline expansion: CAR design and validation, Vector engineering and optimization, Preclinical efficacy and safety studies, Collaboration with clinical partners