Details & Specifications

Laboratory Facilities

Cook MyoSite operates two neighboring facilities with 10,000+ square feet of laboratory space, qualified instruments and equipment, and more than 3,400 square feet of clean room space with ISO 7 and ISO 5 capabilities. Our laboratories are equipped with all standard biologic equipment as well as qualified instruments for manufacturing, processing, and preserving muscle and other adherent cell types. 

 

100 Delta Drive Laboratory
  • Microbiology & QC Labs – 3,477 sq ft

  • R & D Labs – 1,402 sq ft

105 Delta Drive Laboratory & Cleanroom
  • Clean Room – 3,470 sq ft

  • Microbiology & QC Labs – 1,672 sq ft

  • R & D Labs - 922 sq ft

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Analytic Capabilities
  • Cell Count and Viability
  • Custom Gene Expression Assays
  • Sterility Testing - Direct inoculation (USP <71>)
  • Sterility Testing - Membrane filtration (USP <71>)
  • Myogenic Differentiation - Immunohistochemistry 
  • Myogenic Content Assay - Desmin 
  • Kinetic Chromogenic Endotoxin (USP <85>)
  • Myogenic Differentiation-qPCR 
  • Mycoplasma Assay (NAT method-equivalent to USP <63>)
  • pH (USP <791>)
  • Osmolality (USP <785>)
  • Gram Staining/Microbial ID (USP <1113>)
  • Bioburden Testing (USP <61>)
  • FTIR Material ID (USP <197A>)
  • Flow Cytometry
  • Fluorescent Microscopy
  • Growth Promotion of Media (USP <71>)
  • Culture Monitoring 
  • Visual Inspection (<USP 790>)