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Comparative Medicine Institute

GMP Facility for Human Cell-based Products

600+ sq. ft. of cleanroom space with expert staff and state-of-the-art equipment available at low daily rates

Located on the Centennial Biomedical Campus in Raleigh, North Carolina, our ISO 7 cleanroom facility specializes in the production of human cell-based therapeutic materials — under controls consistent with the FDA’s current Good Manufacturing Practices (cGMP) — for use in Phase I clinical trials. 

If your company is developing a cell-based therapeutic product in the Research Triangle area or elsewhere, we have the space, equipment and expertise to help you start producing the GMP-compliant samples you need for Phase I trials as soon as you’re ready. Contact us today!

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What We Offer

  • 620 sq. ft. – Total cleanroom space
  • On-site QC testing lab
  • Extensive network to help you scale up, improve manufacturing methods and optimize your protocol

Why Choose Us

  • Our facility was designed with early-stage startups in mind
  • We work with your technical experts and staff — which significantly decreases costs and allows you to ensure protocols are implemented exactly how you intended — and have the capacity available to help you right away
  • We offer a low daily-use fee and only charge for time spent inside our facility
  • We specialize in the manufacturing of human cell-based therapeutic materials
  • We’re here to help all the way, from starting and preparing your Investigational New Drug (IND) protocol application to manufacturing GMP-compliant materials

Facility Overview 

  • Manufacturing suite with four 150 sq. ft. modules (620 total sqft)
  • State-of-the-art equipment, including incubators, centrifuges, aspirators and more
  • Pre-Gowning, Gowning and De-Gowning rooms

Floorplan

Manufacturing Equipment

  • Aspirator
  • Automated Cell Counter
  • Bead Bath
  • Biological Safety Cabinets (BSL-2) w/ Vent
  • Centrifuge w/ Air-tight Lids and Interchangeable Rotors
  • CO2-resistant Shaker
  • FlashGel ® Electrophoresis and Imaging System
  • Flow Cytometry – QC Only
  • Fully integrated KrosFlo ® KMPi TFF System
  • Incubators
  • Labconco FreeZone 2.5L -50°C Benchtop Freeze Dryer w/ Tray Dryer 
  • Manual Hemocytometer
  • SEM Microscope
  • Thermal Cycler

Contact Us

Phone

919.515.8085

Email

CMIgmpfacility@ncsu.edu