G-CON Manufacturing Builds and Delivers Multiple PODs to Rubius Therapeutics’ cGMP Facility in Smithfield, Rhode Island
G-CON Manufacturing, the leader in prefabricated, flexible cleanroom solutions, announced today that it has successfully delivered to Rubius Therapeutics multiple PODs with included corridors totaling 6,500 sq. ft. of cleanroom space. The PODs will provide the clean environment for Rubius’ allogeneic red cell therapy clinical manufacturing facility in Smithfield, RI. The PODular facility includes areas for cell expansion, cell culture and filling areas. All PODs were built to BSL 2 requirements.
The manufacturing facility boasts flexibility with the cleanroom suites being able to serve different campaigns in parallel. The facility was designed with the cleanrooms and corridor subPODs connecting them. Speed was a critical element for Rubius and achieving an 8-month turnaround (POD order to IQ/OQ) was only possible due to the dedicated and urgent work of all parties involved in the project. Prior to delivery and installation, the PODs were Factory Acceptance Tested (FAT) at G-CON’s manufacturing facility in College Station, Texas, further reducing the time and complexity of installation at the Rubius site.
“From day one, the project team’s mission was to execute this project faster than what many considered possible so that Rubius could accelerate key milestones to support manufacturing for its cancer clinical trials. Strong leadership, concise decision-making and a fully integrated team were key elements in making this project a success,” said Peter Makowenskyj, Director of Sales Engineering for G-CON Manufacturing. “Rubius has been a fantastic partner to work with and their technology is amazing. By harnessing red blood cells and engineering them to tackle diseases in a variety of different ways, these potential drugs could have a profound impact on patients’ lives for years to come.”
“G-CON Manufacturing was an exemplary partner and instrumental in helping Rubius Therapeutics accelerate our plans to have a manufacturing facility capable of producing GMP material for our pipeline of Red Cell Therapeutic™ product candidates for the potential treatment of cancer,” said Spencer Fisk, Senior Vice President of Technical Operations for Rubius Therapeutics. “G-CON’s sense of urgency, flexibility, collaborative approach and creativity made it possible for us to install multiple cleanrooms in record time to meet our timelines.”
About G-CON Manufacturing
G-CON Manufacturing designs, builds and installs prefabricated G-CON POD® cleanrooms. G-CON’s POD portfolio provides cleanrooms in several dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD® cleanroom units surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing the PODs once the production process reaches its lifecycle end. For more information, please visit G-CON’s website at http://www.gconbio.com