GBA provided design services for Ampio Pharmaceuticals’ transition from a start-up to a full-scale commercial operation. This state-of-the-art project included the design and construction of a 19,000-square-foot pharmaceutical production facility involving clean rooms, laboratories, a warehouse and office space for a proprietary biopharmaceutical company specializing in anti-inflammatory treatments.

Project Elements

• Modular clean room for aseptic processing
• Utility design for pure steam, water for injection, compressed air, nitrogen, argon and central vacuum system
• HVAC design for the manufacturing facility (ISO 8 through ISO 5), laboratories, and office/warehouse areas
• Class A corporate headquarters (office design)
• Equipment procurement, including specifications, competitive bidding, vendor recommendations, and FAT/SAT attendance for manufacturing equipment, including:
  – Autoclave
  – VHP chamber
  – Vial Filler with RABS
  – Custom fluid removal machine
  – Pure steam generator
  – Water for injection skid
  – Laboratory equipment
  – Modular clean room