Xcellerex’ FlexFactory® is a bioprocessing manufacturing platform based upon single-use solutions, designed as modules and optimized cleanroom space. The FlexFactory is designed for a specific need, validated, and operated, and then may be transplanted to a new site without issues with proprietary cell lines, media, and technology that may limit a biotech’s future options. Xcellerex operates its own FlexFactory and also sells FlexFactories to clients.
“The automation system used to operate our FlexFactory is a purpose-built, application-specific tool for bioprocess operations, covering both development and manufacturing,” Ken Clapp, senior director of global marketing and product management, explains. “The software integrates the typically separate up- and downstream unit operations and associated equipment into one comprehensive automation environment.”
The result, Clapp says, is a manufacturing facility that can be built and deployed quickly and less expensively than its traditional counterpart. “Integrating automation with disposable manufacturing, with access to contract development and manufacturing services, helps organizations become more productive by aligning manufacturing capacity more closely with regulatory approval,”helping production to start sooner.
One of the concerns in outsourcing aspects of development and manufacturing is the risk that inefficiencies will creep into the system and that critical knowledge will not be transferred successfully. Brian Arnold, brand and marketing manager at Cook Pharmica says that working with a CMO that provides comprehensive service at a single location minimizes wasted time, redundancy, information loss, and the number of relationships that must be managed.