Science & Technology: Manufacturing

Small Volume Parenterals Suite
5,000 SF

   ■  Programmed and designed Small Volume Parenterals manufacturing suite in 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
11,500 SF

   ■  Renovated existing OSD manufacturing facilities to accommodate process changes and compliance with FDA and EMA GMP Standards
   ■  Leveraged BIM to work in 3D with users to develop efficient equipment arrangements, segregation and flow improvements
   ■  Developed 6-phase construction strategy to minimize facility downtime and allow adjacent operations to continue during the upgrade process

Utility Building Renovation
1,700 SF

   ■  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
3,800 SF

   ■  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

Concept Plan for U.S. Manufacturing Facility
320,000 SF in this phase

   ■  Planning studies for the proposed manufacturing facility for US production took two distinctly different tracks both in terms of cash flow over a five year plan as well as in the resultant buildings
   ■  Full build out option (left) and modular option (right) developed to maximize advantages of each design option
   ■  BIM software used to prepare rendered 3D massing and exterior studies as well as 2D functional blocking and stacking concepts