Science & Technology: Manufacturing

Small Volume Parenterals Suite

  • Compliance with FDA and European GMP Standards
  • Integrated project requirement and utility upgrades with multi-phase master plan for manufacturing expansion
  • Led modeling and clash detection for filling equipment, modular clean room construction, and MEP systems resulting in only 6 coordination-related RFI's

GMP Manufacturing Facility Upgrades

  • Renovated existing OSD manufacturing facilities to accommodate process changes and compliance with FDA and EMA GMP Standards
  • 6-phase construction strategy to minimize facility downtime and allow adjacent operations to continue during the upgrade process

Utility Building Renovation

  • Renovated an existing detached storage building to house expansion and replacement of existing on-site waste management and emergency power distribution
  • Building shell upgraded to meet latest energy codes including new energy efficient doors, TPO roofing, EIFS, and building controls
  • System upgrades included new evaporators, building controls, and site services for emergency power, security, and automation

cGMP Clinical Manufacturing Facility

  • Programmed, planned, and designed fit-out of existing shell space with clinical manufacturing facilities for the development of biosimilar assets
  • Facility consists of new warehouse, seed lab, upstream cell expansion, downstream chromatography, and final filtration
  • Designed to be a campaigned multi-product facility through the use of single-use technologies at both 2000 and 200 Liter scales