About the Facility
The evolution of clinical therapies and the advancement of artificial intelligence, automation, single-use technologies, and digitization have updated the requirements for optimal operation of pharmaceutical manufacturing facilities. For the Genentech team, the CSC was an opportunity to do something bold and create a facility that could deliver on the promise of medical innovation while ushering in a new era of manufacturing for the biotech company.
The CSC was completed in November 2022 after 19 months of development. Located in South San Francisco, California, it is a 78,000-square-foot, 2,000-liter-scale, small-volume clinical biologics facility. During design, every opportunity to push the envelope was evaluated, including the facility layout, equipment choices, digitization tools, and team organization. The resulting facility is surprisingly simple and dynamic in its design.
The facility touts a ballroom layout, or open floor plan, eliminating the need for separate rooms and teams. This change from the standard facility design allowed for a product-agnostic layout with downstream flexibility. Because of these design choices, the facility can quickly adapt to producing different therapies while simplifying utility lines and reducing the need for specific equipment.
The design—which includes fully integrated automation, robotics, and operations management systems—also enables a central team to run the facility. Paired with fully digital validation and paperless manufacturing operation, the CSC is built for agility and speed while maintaining high-quality standards for the safety of patients.
Planning for the future went beyond integrating the latest and greatest technologies. Sustainability was an objective the team kept front of mind, beginning with a life cycle assessment of the facility and continuing throughout the facility’s construction. The CSC, now LEED Gold certified, generated renewable energy, significantly reduced energy and water use, and made extensive efforts to minimize waste.
Built to be a template for future Genentech facilities, the CSC mixes technical and operational innovations with a straightforward, strategic approach to facility design. The cutting-edge facility delivers improved outcomes in terms of construction, safety, sustainability, facility productivity, and improved patient access to innovative medicines.
About ISPE’S FOYA
Since 2005, ISPE’s FOYA has recognized state-of-the-art projects using new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
Each year, submissions are accepted from projects worldwide, representing breakthroughs in various disciplines, from automation and integration to the development of medicines for underserved populations. Ultimately, a panel of industry leaders chooses the projects that set the standard to receive FOYA in the following categories:
- Innovation
- Operations
- Supply Chain
- Pharma 4.0™
- Social Impact
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