A Typical FlexFactory Deployment

No two FlexFactory deployments are exactly alike, but a typical scenario works like this:

A biotechnology company will collaborate with Xcellerex's process development team using the PDMax™ Process Optimization Platform and XDR™ single-use bioreactors to develop an optimized process. Depending on the required scale, Xcellerex may configure its inhouse production operation to produce drug for the client until it makes sense to begin moving to a more dedicated, large-scale production mode.

At this point, Xcellerex will configure a FlexFactory production train to achieve the clinical or commercial production requirements for that customer. The Xcellerex CMC team will validate and operate the dedicated train in its own facility on the client's behalf, while also providing live training for the client's staff on all operating and quality procedures. Some customers may have Xcellerex continue to operate the FlexFactory as a long-term solution, while others will use this capability as a bridge mechanism until they receive a BLA and are ready to assume manufacturing control.

Depending on the client's manufacturing strategy, Xcellerex may simultaneously begin working with the client to plan, build or renovate a dedicated production facility at the client's site. Once this site is readied, Xcellerex will plan and deploy a FlexFactory TransPlant™ operation, whereby the existing dedicated FlexFactory production train is temporarily decommissioned, packed and transported to the customer's site. Once at the customer's site, the FlexFactory line can typically be re-assembled, re-validated and re-started within a few weeks.