Regulatory Acceptance

Xcellerex has assembled a team with decades of combined experience in drug development and commercialization. Our people have successfully launched and manufactured new biotherapeutics, and understand the demands of the regulatory process. This deep knowledge base was extensively drawn upon during the design of the FlexFactory, its system components and its operating procedures. We believe we have anticipated and designed to the requirements key regulatory agencies have set forth for biomanufacturing.

Xcellerex has been proactively engaging in dialog with regulatory agencies to ensure mutual understanding of the quality and compliance considerations related to disposables-based manufacturing and the FlexFactory concept of executing individual unit operations in enclosed controlled environment modules co-located in a common manufacturing space.

Xcellerex has been working closely with FDA's CDER and CBER program centers for more than three years and is actively pursuing dialog with the EMEA. We have received positive feedback from our regulatory interactions to date. In 2008 we are planning additional discussions with regulatory groups and to file a DMF providing details of FlexFactory.