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

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>)