Facilities

Paragon’s facilities are designed and built specifically for small-batch production of proteins monoclonal antibodies, recombinant vaccines, and Virus-like particles (VLPs) at smaller scales and under cGMP regulations, suitable for Phase I/II clinical trials, diagnostics or research purposes.

Segregated suites for mammalian, baculovirus or microbial production and purification.

  • Upstream suites are classified as ISO 8 with single pass, positive pressure class 100,000 HEPA filtered air.
  • Downstream suites are classified as ISO 7 with single pass, positive pressure class 10,000 HEPA filtered air
     

Prevention of cross-contamination:

  • Unidirectional flow of personnel and materials
  • Entry and exit airlocks
  • Single-use disposables
  • The suites are monitored by a 24/7 security system and HVAC monitoring system.
  • Environmental monitoring program ensures the suites are cleaned and maintained to cGMP specifications.

 


Contact us for additional information or to request a proposal.