Meet the 2023 FOYA Pharma 4.0™ Category Winner: Genentech
The 2023 Facility of the Year Award (FOYA) Pharma 4.0™ category recognizes companies that embody the Pharma 4.0™ concept. This includes not only implementing one or more technological innovations, but also demonstrating the ability to change their culture, processes, and people orienting them towards a 4.0 future. Significant contributions include application of one or more applied science-based solutions or digital innovations like automation, robotics, digital twin, or advanced processing understanding; substantial improvement to operational practices; or technologies widely and strategically implemented across the organization.
About the Company: Long considered the founder of the biotechnology industry, Genentech is dedicated to pursuing groundbreaking science to discover, develop, manufacture, and commercialize medicines for people with serious or life-threatening diseases. Genentech, headquartered in South San Francisco, California, has provided life-changing medicines for patients around the world for more than 45 years. They have been a member of the Roche Group, one of the world’s largest pharmaceutical companies, since 2009. By the numbers, Genentech has 785,000 square feet devoted to research, 13,500 employees working to solve unmet medical needs, more than 40 medicines on the market, more than 20,000 patents granted, and 39 breakthrough therapy designations to date. In 2021, Roche and Genentech collectively invested nearly $15 billion in Research and Development, more than any other healthcare company in the world.
Project: South San Francisco Clinical Supply Center
New Center, New Company Culture
Genentech’s South San Francisco (SSF) Clinical Supply Center (CSC) leverages highly advanced manufacturing technologies and employs an agile modular design to speed the on-demand delivery of their investigational medicine pipeline to patients in clinical trials. It represents a new model for the fast, efficient production of therapeutics for smaller patient populations by more rapidly translating scientific discoveries into medicines for patients in clinical trials and bringing the promise of personalized healthcare to life. The flexibility of the equipment arrangements that can be accommodated over time, as well as the ability to implement new technologies without requiring building modifications enables Genentech to continuously explore opportunities for future manufacturing innovation. The SSF CSC was designed to leverage the latest digital technologies along with in-house process improvements that significantly increase production flexibility, efficiency, and output while reducing the use of water and energy resources to achieve higher levels of sustainability. Additionally, Genentech took a very deliberate approach with the teams in the CSC to foster a forward-looking, innovative mindset and empower bold, agile ways of working.
Why They Won:
From the outset, the SSF CSC integrated advances in single-use technology with the intention of creating a template for future next-generation, small volume manufacturing facilities. The design concept involved the utilization of standard repeating modular work cells, physical spaces identified for performing a single unit of operation, to meet specific process demands. All product-contacting process steps can be performed in a single, contiguous ISO 9 room called the “Ballroom”. The Ballroom is supported by adjacent ancillary rooms such as an analytical testing area for at-line QC testing.
The Center has been designed to leverage process improvements that significantly increase the amount of therapeutic protein produced, while improving flexibility, increasing process speed, and reducing environmental footprint. Genentech continuously optimizes the production processes with each batch, utilizing new digital technologies to more efficiently produce investigational medicines.
When designing the new state-of-the-art SUT facility, Genentech implemented a new fully digital Commissioning and Qualification (C&Q) system and approach. The approach leveraged concepts from Quality Risk Management (QRM) and ASTM e2500 to apply a standardized modular test methodology to streamline the execution of C&Q activities. As an example of the benefits of the front-end QRM activities in eliminating redundant activities and requirements, this approach enabled the team to prospectively identify an early C&Q deliverable that was historically generated for every system but only actually needed for 20% of the SSF CSC systems. This prospective approach allowed the requirement and associated work to be eliminated for 80% of systems. Furthermore, the QRM approach achieved a 50% cost savings over other similar projects for automation testing.
Early in the design phase of the SSF CSC, robotic components were considered and implemented as part of the project. A prior network proof of concept (PoC) project demonstrated the feasibility of mobile robotic transport for waste collection from waste airlocks. Once technical feasibility was assessed, this specific technology became part of the facility’s design, including the infrastructure for the unit to autonomously navigate doors and elevators in the building. Instead of using personnel time to handle single-use component waste collection, the work could be delegated to a transport robot working 24/7/365.
When Genentech made the decision to build a new clinical supply center, they also made a parallel decision to build a completely new organization to run and support the mission of the new facility. The facility, equipment, and automation designs enable employees to easily and safely learn and grow across different areas of the facility by providing consistency in automation interfaces, visual appearance and layouts, procedures, training, and parts across the entire facility. This is coupled with an equitable and comprehensive approach to learning, training, risk management, and employee development. Genentech provides employees access to the knowledge and the support needed for everyone to practice leadership and independently make confident empowered decisions on a daily basis.
WANT TO LEARN MORE?
Attend the 2023 Facility of the Year Awards Celebratory Reception and Banquet on 15 October at Mandalay Bay Resort in Las Vegas, Nevada, USA held in conjunction with the 2023 ISPE Annual Meeting & Expo.
NOMINATE YOUR FACILITY FOR THE 2024 FOYA PROGRAM!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2024 FOYA program winner. Applications must be submitted by 4 December 2023.
