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Accelerated GxP at Your Service

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™ is here to accelerate your clinical lifecycle, without the burden of facility ownership and maintenance. 

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, Azzur's 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
Cleanrooms on Demand Locations
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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
Put Azzur COD to work for you!
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