Facilities and Equipment

Our FDA and EMEA inspected cGMP-compliant biomanufacturing facilities are located in the United States.

Download the facilities fact sheet

Our facilities are:

• FDA and EMEA inspected
• Ready to host inspections from other international regulatory authorities
• Ready for routine customer audits.

Our facilities can support:

• Cell culture production
• Fermentation production
• Preclinical, clinical and commercial supply.

Global capabilities:

• We offer cell culture capacity to 25,000-L and fermentation to 14,000-L with matching recovery and purification capacity
• We offer cell culture capacity and fermentation capacity to 2,000L with matching recovery and purification capabilities

Diosynth Biotechnology Facilities

Diosynth Biotechnology operates a number of facilities in the Research Triangle Park area of North Carolina. These include a cGMP manufacturing plant offering cell culture and microbial production up to 2,000-L scale and process development and pilot production facilities.  Cell culture capacity is available at scales up to 25,000-L (25m³); and microbial fermentation capacity is available up to 14,000-L (14m³).
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• Process Development
• cGMP Manufacturing
• Quality and Regulatory
• Program Management