The Obvious Choice

Catalyzing the clinical translation of cell therapies by democratizing access to cGMP manufacturing space and expertise.

Significant Supply Limitations

Cell therapy is transforming the face of medicine at a rapid rate. With over 1,000 global Regenerative Medicine companies, the industry stands at the precipice of delivering life-saving and life-altering therapies. However, a lack of access to readily-available and rentable cGMP manufacturing space is stifling the industry’s potential. All product developers need access to cleanrooms to deliver therapies to patients, but the industry has forced them to choose between two equally unattractive options:

Option A:

Build A Custom Facility

  • Incur large capital expense in brick and mortar
  • Must assemble team of experts (architects, engineers, developers, etc.)
  • 2+ years to move-in; must be able to predict future capacity needs
  • Diverts critical resources from advancement of your technology platform

Option B:

Outsource Manufacturing

  • Necessitates costly and time-intensive technology transfer of proprietary information
  • Fraught with scheduling constraints & time delays based on availability
  • Incur large expenses in clean room reservation fees
  • Cede control over your process; must accept limited transparency

We can do better.
Enter Option C

The Obvious Choice

A New Paradigm in GMP Manufacturing

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Your Process. Your Product. Under Your Control.

OrganaBio is building a 19,000 square foot, state-of-the-art, multi-tenant cGMP manufacturing facility in Miami, FL set to open its doors in Q4 2021. Modular cGMP suites can be reserved for short or long term for your dedicated use and come with pre-qualified scientific equipment, private office space, and access to a host of support services. Leverage our support staff, expertise and facility management to rapidly manufacture your product in your suite, using your skilled staff. Maintain control of your process and your IP to manufacture your product. Option C is the perfect solution to get you to clinical manufacturing and beyond.

Facility Features

  • Secured, modular ISO7 clean rooms (with ISO 5 BSCs) and individual HVACs; ISO8 support spaces
  • Ability to support a variety of manufacturing processes
  • Cold-storage space for reagents and media
  • Materials receipt, warehousing and inventory control
  • Private office space
  • Building management system

Support Services

  • Quality assurance
  • Quality control
  • Environmental monitoring
  • Regulatory expertise
  • Logistics
  • Information technology

Gain business agility. Reduce startup timelines and costs.

Option C: Accelerating the innovation cycle of cell therapies.