Nanotherapeutics

Your Biopharmaceutical Development and Manufacturing Partner

The ADM Facility

Nanotherapeutics operates a 183,000 square foot multi-purpose, multiproduct biologics and vaccine facility in Alachua, FL, designated the Advanced Development and Manufacturing (ADM) facility. The ADM facility operates in compliance with cGMP and is ISO 9001 Certified. This facility provides capabilities in analytical testing, process development and scale-up, cGMP cell and viral banking and cGMP manufacturing which can handle pathogens at biosafety levels up to BSL-3.  The capabilities of the ADM include testing, developing and cGMP manufacturing of biologics including:

  • Vaccine products (virus, bacterial and virus-like particles)
  • Monoclonal antibodies from cell culture
  • Recombinant proteins from other platforms (E. coli, yeast, insect cells)
  • cGMP production of Master and Working cell and viral banks
  • Concurrent manufacturing of multiple cGMP bulk biologics via four independent production rooms

The ADM Facility provides the following features:

  • Accommodation of Single-use Technologies (SUT) to provide significant advantages in cost, operational flexibility, and reliability
  • Availability of traditional stainless steel equipment capable of clean-in-place (CIP) and steam-in-place (SIP) for fermentation and cell disruption
  • Process Development Laboratories to accommodate small and pilot scale development work including capability for BSL-3 agents
  • Quality Control (QC) in-process release and stability testing, including BSL-3 agents 
  • Agile, flexible manufacturing based on single-use, skid mounted process equipment in both pilot plant and manufacturing core to facilitate the rapid changeover of process configurations for different platform technologies within production suites
  • The ability to accommodate up to four x 2,000L bioreactors
  • Compliant commercial scale cGMP biologics manufacturing from BSL-1 through BSL-3

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