As you look to start your GMP journey to develop critical therapies, lack of manufacturing infrastructure and compliance expertise can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on Demand™ (COD) is here to accelerate your clinical lifecycle, without the burden of facility ownership and maintenance.
Truly unique to the industry, the Azzur COD hybrid model allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs).
Each cleanroom consists of an ISO 7 core with ISO 8 anteroom/airlocks. Each cleanroom is also equipped with an ISO5 BSC.
A standard cleanroom is 65’ x 12’. The cleanroom suites are 750-sq.-ft. ISO 7/8 with a 500-sq.-ft. ISO 7 core, anteroom, airlocks, & gown in/out. Some cleanrooms may vary.
Yes, our panel-based modular construction allows you to combine up to six adjacent cleanrooms which will provide a 3,000-sq.-ft. ISO 7 core.
Azzur clients can use the space for whatever is appropriate for ISO 7 & 8 spaces, including manufacturing, research, & process development. Our cleanrooms are ideal for early-phase clinical cell & gene therapy, microbiome, cell banking, & small-scale biologics manufacturing. The cleanrooms are designed for primarily closed operations in the ISO 7 areas, with open processing under aseptic ISO 5 conditions (isolators or biological safety cabinets).
Azzur provides non-process-specific equipment such as refrigerators, freezers, BSCs, incubators, etc. Azzur can assist clients with the procurement & routine qualification, maintenance, & monitoring of process equipment, while on-site, as a service.
You should start looking into options up to 12 months in advance with the flexibility to move quickly based on your timeline.
The typical minimum contract duration starts at 12 months; shorter contracts can be negotiated upon discussion.
You would typically need 60-90 days from contract finalization to plan to occupy the cleanroom.
Yes, you can license multiple cleanrooms in a single site or nationally across our network of facilities.
