Nanotherapeutics

Your Biopharmaceutical Development and Manufacturing Partner

Facilities

Alachua, FL ADM Facility

Alachua, FL ADM Facility

Nanotherapeutics is a fully integrated company in which product development programs are matrix-managed collaborations, with a Principal Investigator (PI) and a Project Manager (PM) assigned to each goal along with the related internal staff, subcontractor PIs and personnel, and consultants.

  • A 180,000 sq/ft flexible biologics manufacturing facility located in Alachua, FL
  • Fermentation: 2 lines up to 500 L volume
  • Cell and viral banking / vector development
  • Process Development and transfer/scale-up
  • cGMP pilot / clinical / commercial scale
  • Microbial and mammalian cell culture 
  • Quality control and validation
  • Two BSL-3 / cGMP upstream/downstream/media buffer preparation areas  
  • NANO-ADM capabilities include:
    • Technology Transfer
    • Process Development / Scale-up
    • Cell and Viral Banking
    • cGMP Manufacturing
    • Microbial and mammalian cell culture and purification
    • Quality Control
    • Quality Assurance and Regulatory Support

 


Bohumil, CZ Facility

Bohumil, CZ Facility

The first GMP and BSL-3 licensed plant utilized for the production of cell culture Influenza vaccines.

  • 150,000 sqft  BSL3 facility / 50 acre site
  • Cell Culture: 2 robots / 11,400 roller bottles / year
  • Fermentation: 2 lines up to 6,000 L volume
  • Purification 1: 2 lines / 6 Ultracentrifuges
  • Purification 2: 2 lines / 2 Ultracentrifuges
  • cGMP clinical / commercial scale
  • Quality control and validation
  • State-of-the-art Vero cell-culture vaccines manufacturing capabilities
    • First GMP and BSL-3+ licensed plant in Europe dedicated to production of cell culture influenza vaccines
    • Produce up to 16mm doses of seasonal influenza vaccine annually and 50mm – 180mm doses of monovalent pandemic vaccines
    • Vero cell technology allows vaccine production in just 12 weeks from receipt of virus strain vs. 24 weeks for eggs
  • Facility licensed by EU, Austria, UK, Brazil,  France, Japan
  • Excellence in Safety – over 4 million hours without incident
  • ISO 14001 Environmental Management - certified

 

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