About Xcellerex Biomanufacturing
To help clients manage timing and investment risk, Xcellerex provides access to the FlexFactory® platform and XDR single-use bioreactors through our inhouse FlexFactory biomanufacturing operations. Xcellerex provides complete bridge biomanufacturing operations for short, medium or long-term production needs until your milestones are met and you are ready to begin operating your own facilty. Operating the platform internally also allows Xcellerex to constantly study, refine and enhance the design and operation of the platform.
Our biomanufacturing unit is operated by a world-class CMC team that shares decades of commercial drug production experience.
Operated in dedicated manufacturing space, Xcellerex can offer cGMP manufacturing for clinical and commercial production of mammalian call and microbial/yeast products from fermentation through purification to bulk drug substance.
Xcellerex will coordinate fill/finish activities, stability studies and clearance studies for clients and is very experienced with preparation of CMC regulatory filings.
How the Bridge Manufacturing Approach Can Help
Xcellerex operates our internal biomanufacturing operations as a bridge for clients to access the FlexFactory platform. This can help in many different scenarios:
Xcellerex produces product for Phase 1-2 clinical trials before client commits capital to building a production facility, allowing client to postpone investment decision by 2-3 years.
Xcellerex builds and operates a commercial scale operation until client receives BLA.
Xcellerex offers "surge capacity" to supplement a client's existing FlexFactory production to handle unexpected or temporary demand spikes.
Xcellerex provides rapid manufacturing start-up when client faces sudden, immediate need to manufacture product.
Xcellerex manufactures product during early stages of blockbuster drug start-up while client ramps its own large-scale production.
are developed, manufactured & commercialized.
