G-CON Manufacturing, the prefabricated, flexible cleanroom solution specialist, has delivered multiple cleanroom PODs to FUJIFILM Diosynth Biotechnologies for the build-out at its National Center for Therapeutics Manufacturing (NCTM) in College Station, Texas.
The PODs add 4,000 sqft of needed cleanroom space, providing the extra capacity necessary to accelerate production for COVID-19 vaccine candidate manufacturing.
With time being a critical factor to vaccine production, the cleanroom PODs supported the acceleration of the facility expansion by several months. Offsite manufacturing of the PODs allowed for simultaneous cleanroom and infrastructure construction, significantly reducing the project's overall timeline.
A flexible testing schedule and approach further enabled a faster delivery speed while maintaining GMP assurance.
"Our entire team is pleased to be part of this important project to help ready FUJIFILM Diosynth Biotechnologies' facility for mass production of COVID-19 vaccine candidates," said Jose Negron, Sales Engineer for G-CON Manufacturing. "Drawings, User Requirement Specifications, submittals and diagrams were reviewed with FUJIFILM Diosynth Biotechnologies' team the first week of the project."
"Having these important documents approved early on, allowed G-CON to procure materials in an expedited manner and begin fabrication of the cleanrooms almost immediately," added Negron. "FUJIFILM Diosynth Biotechnologies' team was very responsive, open and approachable, allowing us to be proactive and work diligently to deliver the PODs on time."
"We are thrilled to be part of the rapidly expanding Texas biotech community, and are proud to partner with a Texas-based business to increase our capacity and advance tomorrow's medicines," said Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, Texas.
The PODs were designed and built with a robust HVAC system that allows FUJIFILM Diosynth Biotechnologies to decontaminate the rooms between batches using Vaporized Hydrogen Peroxide (VHP). The POD's automation system was also configured to allow FUJIFILM Diosynth Biotechnologies to change the room pressurisation scheme to meet product-specific parameters and GMP requirements.