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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Early-phase manufacturers face a myriad of challenges when it comes to starting up and scaling out:

  • Need for clinical manufacturing capability
  • Lack of GxP expertise
  • Limited quality management systems
  • Lengthy facility design-build timeframes
  • Insufficient warehouse and materials storage

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).  

Comprehensive Early-Phase Manufacturing

Azzur Cleanrooms on Demand™ offers a hybrid early-phase manufacturing model geared specifically to the challenges you face in the early lifecycle. From speed to clinic to IP protection to flexibility, Azzur COD allows you to run the show when it comes to your project. 

Harness Control over Production
Higher control over process changes

Direct access to facility infrastructure

Control over production schedules
Maintain Flexibility
COD allows for flexibility to pivot and identify failures faster

Located in biotech clusters throughout the US
Experience Cost Savings
Elimination of capital costs, costs of tech transfer failures, and schedule changes
Increase Speed to Clinic
CMO = 6-12 months

Self-owned = 12-24 months

COD = 1-3 months
Enhance IP Protection
CMOs require access to IP to develop process and deliver product

With COD, you maintain full facility access and control of your IP
Our Locations

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Coming 2024
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San Diego
Coming 2024
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San Francisco
"Azzur Cleanrooms on Demand has been a trusted and reliable partner of Editas Medicine for nearly three years, providing us with the dedicated, cGMP-compliant space necessary to support our clinical manufacturing and quality management, which are critical components to making medicines."
Harry Gill Senior Vice President, Operations, Editas Medicine
"With Azzur’s "on-demand" cleanroom, material sourcing, and on-site material storage, we leveraged a cost-effective solution that extended the runway for our early-phase project. Azzur Group’s “hybrid” model is indeed ideal for sponsors who wish to leverage in-house expertise in a safe, timely, and compliant manner."
Rick Ong Head Of Quality Assurance Synlogic

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™