Clinical Lentivirus/AAV Manufacturing Facility
Challenge from the Client
Our client required an "out of the box," fast-track execution strategy to bring their clinical gene therapy manufacturing facility from business case to installation and operational qualification in 12 months.
Our Approach & Solution
IPS proposed their iCON delivery strategy, an offsite fabricated modular solution composed of a series of cleanroom "boxes" or PODs, engineered around the clients manufacturing process. The iCON team took their pre-engineered ÜBERcellFLEX24 modules and optionalized them to meet the gene therapy process requirements, effectively shaving several months off the design and fabrication schedule. The ÜBERcellFLEX units were constructed and FAT'd in a factory in Ireland before being shipped to the construction site in Europe.
Our client was able to fast-track their project in an adjacent factory model to their normal business operations. They were able to procure a single source EPCMV solution for the entire project that included both onsite and offsite design, procurement, construction and qualification.