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Overview
Bill Lydon discusses the new Genentech Clinical Supply Center with Benedicte Lebreton, Vice President of Genentech and Head of Technology Development at Biologics US.
I am working with Genentech Vice President Benedicte Lebreton and Head of Technology Development for US Biologics to create a new small-batch biologics flexible manufacturing facility that will implement manufacturing concepts, innovations and technologies that will serve as a model for future expansion. Discussed the Genentech Clinical Supply Center. The Clinical Supply Center has implemented much of what the BioPhorum Digital Plant Maturity Model describes as the highest level of next-generation manufacturing, a Level 5 adaptive plant. Disposable technology is fundamental to achieving the facility’s goals, such as flexible manufacturing and environmentally sustainable production.
Genentech, a member of the Roche Group, is a founder of the biotechnology industry and a pioneer of the processes and technologies used in the commercial manufacture of complex biological medicines. The Clinical Supply Center is part of the Roche Global Manufacturing Network and one of his three manufacturing locations in California. Roche and Genentech manufacture medicines at 11 locations around the world. In 2021, Genentech has provided more than 55 million vials to patients.
Clinical Supply Center Facility
The facility will serve as a new model for the rapid and efficient manufacturing of therapeutics for small patient populations, including personalized and rare disease medicines. New facility is designed with efficiency and sustainability in mind and is LEED Gold certified, globally recognized as a green building that is healthy, efficient, low carbon and cost effective doing.
The 78,520-square-foot facility supports digitization from product definition through production, with over 19,000 feet of network cable and over 1,000 digital connections (approximately one for every 75 square feet) connecting people and equipment. increase.
system architecture
The digital manufacturing automation architecture consists of LIMS (laboratory management system), drug substance DMS (discrepancies management system), EDMS (electronic document management system), EMS (environmental monitoring system), CMS (calibration management system), PLM (product management system) ) to integrate all systems including Lifecycle Management), DCS (Distributed Control System), and BAS (Building Automation System).
discussion
Benedicte Lebreton explained that the project was a success without any unexpected operational problems. She said the project achieved design requirements including:
- Rapid and seamless technology transfer from research to clinical manufacturing using a product lifecycle management system.
- Standard plug-and-play utility and data connection for Single Use Technology devices.
- Integrated paperless digital manufacturing.
- Facility, equipment design, and layout allow rapid reconfiguration of production.
- Parameter-driven workflows allow workflow reuse across unit operations and molecules.
- A closed system that allows true ballroom configuration of the process.
A key benefit is that the Genentech team’s learning experience has created a reliable design template for building and operating flexible facilities.
sustainability and efficiency
The facility has demonstrated excellent sustainability and energy efficiency results in operation, furthering Genentech’s long-standing commitment.
- 25% reduction in overall energy usage
- 100% of electricity from renewable sources
- 28% reduction in water usage compared to other facilities
A key contributor to energy savings is the use of disposable technology that does not require Clean In Place (CIP), thus using less water and steam.
Single-use technology shortens the time from scientific discovery to clinical manufacturing, enabling faster delivery of new drugs to patients in clinical trials while using fewer resources. Benedicte Lebreton emphasizes: Nothing to landfill from the facility! ”
Lebreton continues. The waste-to-energy process burns waste to produce steam for power generation. Combining this process with water and energy savings can reduce your carbon footprint by 14%. He also has a recycling program for other items such as gloves and cardboard, a cleaning and reuse program for safety glasses, and many upcoming pilots of soft plastics to reduce the solid waste stream. ”
“We are very proud of our new collaboration with a local hard plastic recycling company that has established a truly circular economy. converted into items such as pipette tips and centrifuge tubes that you repurchase for use in
One of Genentech’s sustainable partners is Polycarbine resource management company, dedicated to transforming the disposable scientific supply chain into tomorrow’s sustainable circular economy. The company reuses waste plastic for other uses.
Genentech Industry Commitment
Genentech is a member of the Roche Group, committed to supporting industry initiatives and organizations such as NAMUR and BioPhorum (also known as BPOG), and participates in a number of ‘operating groups’. Proprietary in nature. Genentech and Roche have inspired many white papers and deliverables from his BPOG, incorporating best practices from her BPOG where applicable.
As a side note, Genentech has been an active contributor to the Pharmaceutical Automation Roundtable (PAR), which I have been involved in and described in articles such as:
consideration and consideration
This is a great example of applying next-generation manufacturing concepts to achieve flexible and environmentally sustainable production.
I asked Benedict Rebreton what was on her wish list. She said she wanted a more ideal sensor for her disposable. This is a new field and we have spoken with several companies working on and improving single-use sensor designs. Both agreed that progress was on track, given that short-term, single-use areas existed.
Interestingly, at the 2019 Pharmaceutical Automation Roundtable, the consensus was that the technology enabling the BioPhorum Digital Plant Maturity Model Level 5 Adaptive Plant is not yet ready. Since that time, Genentech’s project has focused on flexible small-batch production.
About the author
Bill Lydon brings over 10 years of writing and editing expertise to Automation.com, plus over 25 years of technology design and application experience in the automation and controls industry. Lydon started his career as a designer of computer-based machine tool controls. In his other positions, he applied programmable logic controllers (PLC) and process control technology. Working in a large company, Lydon spent two years as part of a task group of 5 people where he designed a new generation building including controller, network, monitoring and control software.He designed an automation system. He also designed software for optimizing the chiller and boiler he plant. Bill was a product manager for a multi-million dollar control and automation product line and later co-founder and president of an industrial control software company.
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