US-Based Biotechnology Company

Genesis provided architectural and engineering services for a new two-story, 338,000 square-foot oncological products and sterile manufacturing facility. The facility includes pharmaceutical manufacturing, warehouse, laboratories, administrative offices, and utility space (CUB), all connected by a central corridor spine following a “Linear Factory” organizational concept.

Our design approach involved relocating the stair towers to the exterior of the manufacturing block and using refined materials to soften the facility’s appearance. Our design included offices, a break room, training facilities, and a visitor entrance.

We enhanced the facility’s aseptic manufacturing capabilities with new filling lines for vials, syringes, and IV bags. The layout accommodates both RABS and isolator technologies and terminal sterilization for bag products. Sterile supplies processing capabilities were also added, featuring autoclaves, dry heat ovens, and washing facilities.

Our services encompassed regulatory strategies, cGMP flow diagrams, HVAC, structural designs, and clean utilities (including WFI, Clean Steam, and CDA).

Glossary:

• Aseptic Manufacturing: The production of products in a sterile environment to prevent contamination.
• Filling Lines: Equipment used for filling containers such as vials, syringes, and IV bags with pharmaceutical products.
• RABS: Restricted Access Barrier Systems, a technology used to maintain aseptic conditions during pharmaceutical manufacturing.
• Isolator Technologies: Enclosed systems that provide a sterile environment for manufacturing.
• Grade B and Grade C Performance: Different levels of cleanliness and control within a sterile environment, as defined by industry standards.
• Terminal Sterilization: The process of sterilizing products after they have been packaged and sealed.
• Autoclave: A device that uses steam and heat to sterilize equipment and materials.
• Dry Heat Oven: An oven used to sterilize items using dry heat.
• HVAC: Heating, Ventilation, and Air Conditioning systems that regulate environmental conditions.
• Clean Utilities: Essential services such as purified water (WFI), Clean Steam, and Compressed Dry Air (CDA) used in pharmaceutical production.
• Water for Injection (WFI): Purified water used in pharmaceutical production processes.
• Clean Steam: Steam that meets stringent purity standards for use in pharmaceutical applications.
• Compressed Dry Air (CDA): Compressed air that has been treated to remove moisture and impurities, used in various pharmaceutical processes.