Applied Gene and Cell Therapy Center
Facility and Services

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 55,000 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 5 and 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
FACT-accredited facility

All personnel are highly trained and operate under strict cGMP/GTP guidelines with full QA oversight.

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)
P24 titers (ELISA)
Mycoplasma, endotoxin testing
Flow cytometric sample analysis
Interferon gamma ELISpot assays

Additional services are available upon request.

Meet the Team