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Our Facility

Design Characteristics

We offer state of the art suites and clinical expertise to University Scientists, Academic and Industrial partners

cGMP Facility

  • 3600 sq.ft GMP Facility
    • Construction: 2011
    • Operation: 2012
  • Manufacturing Rooms
    • 3 suites class 1,000 (ISO 6)
    • 2 biosafety cabinets per suite (ISO 5)
  • Intermediate entrance and exit (ISO 7)
  • Gown in and De-Gown area (ISO 8)
  • Quality control lab (GMP testing lab)
  • Autoclave room
  • GMP storage room
  • Positive-Negative room pressurization

Facility Layout

plan

Controlled environment design features include the following:

researchers in facility

  • Redundant air handling systems providing clean-room air classification and quality from Class 100,00 (ISO 8) to Class 100 (ISO 5)
  • Pressure differentials of 0.05” w.c. between adjacent rooms with up to 60 air changes/ hour
  • Rigorous control of room temperature, differential pressure and relative humidity
  • Environmental control program
  • Unidirectional flow of personnel, raw materials product, and waste
  • Engineered for easy and effective cleaning, utilizing stainless steel surfaces, gel-coated polymer walls and ceilings, epoxy coated floors, minimal seams and ledges; and movable equipment and work surfaces
  • A central monitoring system to monitor, record and document all facility and equipment physical parameters
  • All manufacturing equipment and utilities are validated in accordance with biopharmaceutical standards  (IQ/OQ/PQ).
  • Access to the facility is controlled

Quality Control Laboratory (GMP testing lab):

microbiology 

  • Protein purification by chromatography 
  •  UPLC
  • Cell ID, purity and activity ICC / PAGE (SDS, Native, IEF, Western) and ELISA
  • Microbiology testing (Mycoplasma, Endotoxin, Gram Stain and Sterility)
  • Particle counters (Total and viable)

The USCGF has successfully completed a type C meeting with the FDA in which the facility design, intent of use, operational flow, and quality management system were reviewed in detail.

Contact

Luisa Caetano Davies

Luisa Caetano-Davies
Executive Director, Upstate Cell Therapy cGMP Facility
585.276.6208
E-mail