JN-International Medical Corporation - Vaccine Facilities

Vaccine Facilities

JNIMC facility was designed for manufacture, research and development of human vaccines in compliance with FDA compliant cGMP (Current Good Manufacturing Practices) and European Union Good Manufacturing Practice standards. The facility has fermentation, formulation, vial, freeze drying bacterial facilities classified as Biosafety Level 2 (CDC-NIH BL2-LS) and ISO 9001. The facility includes both the upstream and downstream operations when the fermentation process is scaled up for bacterial polysaccharide product development. The facilities were designed for manufacture of vaccines in compliance with cGMP and European standards. The facility has fermentation, formulations and lyophilization and handling of bacterial polysaccharide products. Utilities include Water-For-Injection Grade Water (WFI) system, oil-free compressed air system (USP), clean steam system, process chilled system and Clean-in-Place systems. Processes include; seed bank, media preparation, fermentation, cell harvest, centrifugation and purification including ultra filtration. The facility operates with SCADA (supervisory control and data acquisition) generally refers to industrial control systems (ICS). JNIMC's cGMP vaccine facility spans 82,000 ft² and will include a 20,000 ft² fully automated unit. The facility has a targeted production of 60 million doses of vaccine annually.

• cGMP vaccine facility.

• cGMP facility inside.

• 1000 liters Bioreactors.

• Vialing Station.