OrganaBio GMP Manufacturing Facility

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:

Self Manufacturing

Bring your staff on-site to manufacture your product under your SOPs. OrganaBio will train your staff on facility protocols and procedures and provide support as requested. This option eliminates the need for third party technology transfer allowing you to maintain complete control of your process and your IP to manufacture your product.

Contract Manufacturing

Rather than having to employ your own manufacturing staff, tech transfer your project to OrganaBio to allow us to manufacture your product to meet your specifications. This option allows you to focus on internal process and product development while OrganaBio experts work in parallel to manufacture your clinical product.

We can do better.
Enter Option C

The OrganaBio GMP Manufacturing Facility

A New Paradigm in GMP Manufacturing

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

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Your Process. Your Product. Under Your Control.

OrganaBio is offering cell therapy developers a new paradigm in contract manufacturing solutions.  OrganaBio’s 19,000 square foot, state-of-the-art cGMP manufacturing facility in Miami, FL can be reserved for short- or long-term projects for your dedicated use.  Use of the facility provides access to advanced process development suites, ISO 7 cleanrooms, and an on-site analytical testing core all equipped with pre-qualified scientific equipment.  OrganaBio provides a host of support services including materials receipt, inventory management, ambient and cold storage, environmental monitoring, and facilities maintenance.  Our model offers flexible manufacturing solutions to meet your unique and evolving needs as your program matures.  Leverage our support staff, expertise, and facility management to rapidly manufacture your product whether it’s through self-manufacturing, contract manufacturing, or hybrid manufacturing.

Facility Features

  • Secured ISO7 cleanrooms (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
  • Dedicated 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.

OrganaBio: Accelerating the innovation cycle of cell therapies.