Offering a State-of-the-Art Facility and Comprehensive Gene and Cell Therapy Services
The Applied Gene and Cell Therapy Center operates within a purpose-built space spanning approximately 13,000 sq ft. It includes:
- Vector R&D laboratories
- Three vector cGMP manufacturing suites
- Cell R&D laboratories
- Four cell cGMP manufacturing suites
- Analytical development and quality control laboratories
Cleanroom Features
Our cleanrooms are designed to meet the highest standards of safety, compliance, and performance:
- Certified ISO Class 7 production suites with ISO Class 8 support areas
- 24/7 Automated Particle Measuring System
- Uninterrupted power supply and emergency backup systems
- Independent CO₂ gas supply with automated backup
- Redundant HVAC system for environmental control
- Integrated Building Management System with personnel alarm notifications
- Controlled Access System for secure operations
All personnel are highly trained and operate under strict cGMP/GTP guidelines with full QA oversight.
Our Services
We specialize in the development, production, and characterization of complex cell and gene therapy products, including:
- Genetically modified cells: CAR-T, TCR-T, NK cells, macrophages, CD34+ stem cell-based gene-corrected products
- Viral vectors: Retroviral, lentiviral, and adeno-associated viral (AAV) products
These products support Phase I and Phase II clinical trials under FDA IND applications.
Service Portfolio
- Vector Product Development and GMP Manufacturing
- Cell Product Development and GMP Manufacturing
- Analytical Development, Testing & Quality Control
- Platform Development
- Tech Transfer
- Additional CGT Product Development Services (available upon request)
Platform Capabilities
Our platforms are designed to support a wide range of therapeutic approaches:
- Transient transfected retroviral (RVV) and lentiviral (LVV) vectors
- Stable retrovirus-producing cell lines
- Immunotherapy platforms: CAR-T, TCR-T, NK cells, macrophages
- CD34+ stem cell gene correction using lentiviral vectors
- Full and conditional product release
- Comprehensive analytical development and characterization
Quality Assurance and Compliance
Our dedicated Quality Compliance Team ensures regulatory alignment and operational excellence across all activities.
Responsibilities Include:
- GMP and GTP training
- Internal audits and compliance reviews
- Approval of critical documents
- Raw material and product disposition
- Label and batch record management
- Complaint investigations
- Supplier qualification
- Oversight of deviation, document control, change control, and annual review systems
- Facility registration and core deviation reporting
We also provide consultation and training to academic and industry partners on GMP requirements, cleanroom design, and validation.
Specialized Laboratories and Services to Support Internal CGT
From bench to bedside, we collaborate with principal investigators to translate research into clinical applications.
Cell Manipulation Labs
- Cell subset enrichment/depletion
- Genetic modification (transduction)
- Expansion and differentiation
- Cryopreservation and stability studies
- Thawing and infusion preparation
Islet Isolation Labs
- Isolation for research and clinical use
Viral Vector Labs
- Lentiviral, gamma-retroviral, and AAV vector production
Characterization and Testing Labs
- Infectious titer (flow cytometry, qPCR)
- Puromycin and P24 titers (ELISA)
- Sterility, mycoplasma, endotoxin testing
- Flow cytometric sample analysis
- Interferon gamma ELISpot assays
Additional services are available upon request.
