Full-service FDA Registered Outsourcing Facility/Compound Pharmacy

• Four Aspects of Compounding Capabilities
  • USP 800 Sterile Hazardous
  • USP 800 Non-Sterile Hazardous
  • USP 797 Sterile Non-Hazardous
  • USP 795 Nonsterile Non-HD
• 3 Production Suites
• Registered Pharmacist on Staff
• Key Activities
  • Funding and Design – Completed
  • Equipment (BSC/Hoods) Procurement – Completed
  • Procurement of Materials/Space Buildout – Target May
  • Clean Rooms/Equipment Qualification – Target May
  • Establishment Application w/FDA & State Board Pharmacy – Pending

• Formulation and Lyophilization Development
• Method Development
• Pilot Scale Manufacturing

• Validated Stability Chambers
• Full UPS and Generator Backup
• 25C / 60% RH (long term)
• 30C / 65% RH (intermediate)
• 40C / 75% RH (accelerated)
• 2C to 8C (refrigerated)
• -20C (frozen)
• -80C (frozen)
• -140C (frozen)
• Photostability Chamber

• Full scale GLP Testing Capabilities.
• Assay development across a variety of target types and therapeutic areas using a broad range of formats for low to high-throughput applications.
• Custom Cell and Molecular Biology Research Services.

• PhD scientist who is an expert in Cancer cell development
• Expertise in cell-based assays to support early-stage drug development
• Assay development across a variety of target types and therapeutic areas using a broad range of formats for low to high-throughput applications
• Preclinical Validation of Therapeutic Leads
• In Vitco efficacy testing
• Example Readouts
• Cytotoxicity & Cell Proliferation Assays
• Real-Time Apoptosis/Necrosis Detection
• Migration/Invasion Assays
• Transformation Assays
• Deconvolution of mode of action
• Cell Signaling Analysis
• Molecular and Genetic Analysis
• Biomarker Validation
• Custom Cell and Molecular Biology Research Services
• Full library/cell bank of human and mouse cells