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
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>)