GENENTECH: Investing in the Future of Manufacturing

Article provided by Genentech

In the more than 45 years since Genentech launched the biotechnology industry and pioneered the processes and technologies used to commercially manufacture biologics, the company has evolved to make medicines more efficiently at scale and deliver them as quickly as possible to patients with serious, life-threatening conditions.

In 2021, the combined Genentech and Roche global manufacturing network produced more than 55 million vials of medicine for patients around the world. Today, Genentech uses protein engineering to make complicated types of biologics such as bispecifics that enable simultaneous binding to two different disease targets.

While just four decades ago it was challenging to produce grams of these transformational medicines, the future of manufacturing now relies on nimble processes to produce smaller, personalized medicines that can have an even greater impact on patients.

“Genentech’s new Clinical Supply Center is at the forefront of a modern manufacturing evolution,” says Jeff Davis, executive director, Clinical Supply Center. “Keeping pace with the increasingly personalized nature of health care, it presents a new model for small-batch manufacturing that enables speedier bench-to-bedside delivery of clinical trial medicines and more agile production of potential therapeutics for smaller patient populations, including those with rare diseases or specific biomarker-driven subtypes of cancer.” Genentech has invested more than $250 million in this innovative biologics facility, which is the latest example of our long-standing commitment to our California operations as well as our dedication to environmentally responsible manufacturing practices.”

A Peek Inside The Clinical Supply Center

The Clinical Supply Center will produce investigational medicines from Genentech’s Research and Early Development group for delivery to patients in clinical trials.

This new facility has been designed to leverage process improvements developed in-house that significantly increase the concentration of therapeutic proteins while improving flexibility and speed, and reducing their environmental footprint. Bioreactors are also located in a contained manufacturing area within a single open space production floor – known as a “ballroom” - that allow the company to rapidly reconfigure equipment for various scenarios and scales. Through artificial intelligence and new digital technologies, Genentech continuously optimizes for what the cells need to thrive, producing these investigational medicines faster.

Advancing Sustainable Manufacturing

The Clinical Supply Center enables Genentech to produce more clinical trial medicines in smaller volume batches at an unprecedented speed and with less impact on the environment. For example, the bioreactors are lined with single-use, soft plastic bags protecting the cell material from touching the metal. This eliminates the need to clean and sterilize the bioreactors after each manufacturing run, which significantly reduces the amount of water, steam and chemicals used. This innovative approach means the Clinical Supply Center uses 28% less water compared to other facilities.

“It may sound surprising, but single-use technology is a more eco-friendly option for biologics manufacturing. Not having to clean or generate steam means we can significantly cut back our energy, water, and chemical use, which is critical given our location in drought-prone California,” said Dante Lee, Genentech senior director, Production Support. “None of our plastic goes to landfill. We are currently recycling, downcycling or converting used materials into energy as well as exploring new circular economy solutions to further reduce our environmental impact.”

The company has made significant progress toward reducing their overall environmental footprint. The Clinical Supply Center uses 25% less energy overall and sources 100% of its electricity from renewable sources, including onsite solar generation. The facility has earned LEED Gold certification from the U.S. Green Building Council and all of Genentech’s manufacturing sites have been registered with the U.S. Department of Energy's Better Climate Challenge enabling Genentech to share best practices with other companies around the country. Both the Clinical Supply Center and the new manufacturing facility in Oceanside, CA are important examples of how Genentech is advancing toward their corporate sustainability goals to reduce their greenhouse gas emissions by 40%, water use by 20%, total landfill waste by 20% and plastic waste by 20% at their South San Francisco campus by 2025. The company is also on a path to achieve true zero emissions by 2045.

The new commercial biologics facility on Genentech’s Oceanside campus will be the first of its kind in the Roche global manufacturing network dedicated to full scale commercial production and is part of a $450 million investment in advanced manufacturing capabilities in Oceanside. Modeled after the Clinical Supply Center, the facility will incorporate the same technologies and sustainability practices, and, by standardizing the design of the two facilities, the amount of time needed to transfer production from the clinical to commercial site will be significantly reduced. Once the new facility is operational in early 2025, it will just take a matter of days – instead of the traditional six to eighteen months – to complete this process, getting medicines to patients faster.

After more than four decades at the forefront of biologics manufacturing innovation, Genentech is now at the vanguard of a new movement in manufacturing. Starting with the Clinical Supply Center as the flagship location, and with the new biologics manufacturing facility in Oceanside, Genentech has made significant progress on what will ultimately expand to become a core and integral part of their manufacturing network of the future.