GMP Vector Production

The Vector Production Facility manufactures lentiviral and retroviral vectors in a cleanroom facility that is compliant with FDA’s current Good Manufacturing Practices (cGMP) for the manufacturing of viral vectors in support of early phase clinical trials. The facility has been in operation since 2005.

Services include large-scale GMP lentiviral and retroviral vector and small to mid-scale GMP-like manufactured products. We support certification and stability studies. Quality compliance staff provide regulatory and quality direction and support.

Our Services

The Vector Production Facility is able to support researchers through technology transfer, process development and scale-up using cGMP-compatible methods.

GMP services:

• Gamma-retroviral vectors
• Lentiviral vectors
• Master and working cell banks

Feasibility and pilot scale manufacturing:

• Gamma-retroviral vectors
• Lentiviral vectors

Vector stability studies

Our Facility

The production facility consists of approximately 1,600 square feet of controlled-access space that includes three independents ISO Class 7 cleanroom suites equipped with biosafety cabinets for aseptic processing.

The facility offers these features:

• ISO Class 7 production suites with ISO Class 8 support areas
• Unidirectional flow of personnel and materials for multisuite labs
• Integrated 24/7 Automated Particle Measuring System
• Uninterrupted power supply and emergency power systems
• Independent CO2 and N2 gas supply with automated backup
• Dual Independent HVAC system with redundant fan design
• Integrated Building Management System with personnel Alarm Notification System
• Independent Controlled Access System