Challenges for Controlled Non-Classified (CNC) Multi-Product Drug Substance Facility Design and Operation

Biopharmaceutical drug substance facilities have been traditionally designed with extensive use of clean room space that is considered controlled and classified (ISO-5 to ISO-8 and/or Class A to Class D). An industry based collaboration group, The BioPhorum Operations Group (BPOG) has developed a conceptual framework to expand the use of Controlled, Non-Classified space (CNC) with concurrent use of closed systems for industry and regulatory consideration. This talk will review the concepts, some challenges and proposed strategic solutions, and how we are moving forward to engage with regulatory bodies.