Azzur Cleanrooms on Demand™

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You Bring the Science, We Bring the Compliance®

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.


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Azzur Cleanrooms on Demand™ Advantages

Getting drugs to market is complicated and it’s sometimes difficult to navigate FDA regulations, manage GMP facilities, and protect your intellectual property. Azzur Cleanrooms on Demand™ offers a hybrid manufacturing model geared specifically to your challenges in the early lifecycle. 

Speed to Market
At Azzur, clients own their
processes & schedules; cut
lengthy tech transfers & CMO/
CDMO wait times, & forego long
construction timelines.
Intellectual Property Control
Because Azzur does not
manufacture the product,
clients retain all IP & process
development with no risk of
disclosure.
Flexibility
Azzur cleanrooms & the ancillary
services minimize the need for
long-term commitments & provide
an unmatched cost to value with
as much as 80% first year savings.
Breadth of Services
Azzur Group offers GMP
consulting & advisory services,
aseptic & GxP training, & full-
scale analytical GMP laboratory
services, ready to serve all COD
clients.
Capital Preservation & Risk Management
No upfront capital costs & flexible
terms for contract duration & off-
boarding allow you to preserve
capital & reduce the risk associated
with real estate ownership,
management, & GMP compliance.
Preferred Partner
Privileged relationships with
technical & compliance consulting
service providers, life science
industry consumable & equipment
suppliers, & GMP Labs.

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Frequently Asked Questions

 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.

Put Azzur COD to work for you!
From Discovery To Delivery™