South San Francisco/Oceanside/Vacaville, California

CA’s iconic biotech manufacturer pivoted into the COVID fight with life-changing results. SVP Andi Goddard describes the company’s rapid response and key partnerships, protecting employees to wage the battle, and the future for a California stalwart. 

Founded in 1976, Genentech is known as the pioneer of biotechnology. Headquartered in South San Francisco — the birthplace of the industry — the company, which merged with Roche in 2009, is dedicated to discovering and developing medicines for people suffering from serious and life-threatening diseases including cancer, multiple sclerosis, and COVID-19.

With manufacturing facilities in South San Francisco, Oceanside, and Vacaville, Genentech is also a major California job creator. And as a manufacturer of two FDA emergency use authorized medicines for the treatment of COVID-19, they’ve been at the forefront of innovation throughout the pandemic.

Andi Goddard / All photos courtesy Genentech

CompanyWeek recently spoke with Genentech and Roche Senior Vice President and Pharma Technical Operations Global Head of Quality and Compliance Andi Goddard about the company’s experience as a manufacturer of critical medicines during the pandemic, its future in California and the biotech industry, and current challenges, opportunities, and needs.

CompanyWeek: Genentech had a medicine approved for emergency use during the pandemic. It must have been exciting to play such an important role at this critical time in U.S. history.

Andi Goddard: One of the things I loved about Genentech when I first started and what I continue to really respect is this can-do attitude and willingness to really go the extra mile because our people are so passionate about the purpose we have. We’re here to better people’s lives. I think that’s what made it possible for us to do the work that we’ve done during the pandemic.

We have a medicine called Actemra® that is for the treatment of [hospitalized patients with] COVID-19. We did an incredibly fast tech transfer for it and have manufactured a huge amount of it in California. We really had to work differently in order to use our manufacturing capacity in a way where we could maximize the production of Actemra so that it could be used for this emergency use authorization. And it’s not just people in the United States that we have to think about. The pandemic is everywhere, so it’s not just the U.S. that is clamoring for this medicine but also the rest of the world.

We also partnered with Regeneron on another medicine that received emergency use authorization, which is a neutralizing antibody with the trade name of Ronapreve™(casirivimab and imdevimab). We collaborated with them to develop the process, manufacture the product, and then distribute it. The tech transfer was done in four months, when it generally takes 10 to 16 months for a transfer of that magnitude.

Technician setting up a 2,000 liter outlet panel for activities. South San Francisco, CA.

It was a really great example of not only the collaboration and willingness to serve patients we have within Genentech but also that spirit across the pharmaceutical industry. We’re here to work together to help solve the pandemic.

CW: It sounds like you had to really innovate to get these drugs to the people who needed them.

AG: We had to look at our technology transfer process and dramatically improve its speed in order to get the medicine to patients faster. This took an incredible amount of prioritization, asking ourselves challenging questions about what was truly needed to move it forward, and really looking at radically simplifying some of our traditional processes.

We also have medicines that are for cancer and other serious conditions. How do we ensure that we don’t have something happen that prevents us from being able to manufacture those medicines? We had to really look at what we could do to protect the staff that needed to work on site manufacturing products to ensure that they remained safe from COVID-19. We had to think about what testing we should do and safety measures we needed to put in place to protect the physical and mental health of our employees. And we had to think about how to continue moving the business forward for folks who were able to work remotely.

CW: Did you have to increase your manufacturing in 2020 to accommodate these new demands?

Media filtration system. These filters help sterilize the media (food) that cells use during the growth process. Vacaville, CA.

AG: Our facilities in California have traditionally been very full. We didn’t increase the physical capacity of our facilities, but we really looked at how we were using them and how we could minimize time between batches to eke out every gram of product possible.

CW: Did the COVID-19 pandemic alter the future direction of Genentech in any way?

AG: I think we’d be hard pressed to find any company that could say that the pandemic hasn’t altered their direction in some way, shape, or form. For us, it was a big eye opener to look at the healthcare system and see how it works when it comes to race. The pandemic has really illuminated some of the inadequacies. We need to make sure we’re doing clinical trials in a way that is really telling us how [the medicine] is going to be tolerated and the efficacy for all races, as well as ask ourselves if we’re working to ensure that everyone has equitable access to [the finished product].

We’ve done a lot in the last year to look at how to do better in the racial diversity of our work. We’ve engaged with over 90 patient organizations and formed alliances with different clinical institutions, government, academia, and industry to increase the diversity in clinical research. As you saw from the data shared across media, minority populations have been disproportionately affected by the COVID-19 pandemic. It was really important to understand what we could do to help.

CW: In what ways is Genentech planning to grow this year?

AG: I think one of the wonderful things about Genentech and Roche as a company is that our pipeline continues to be really exciting. It’s not just traditional modalities but also new modalities for more personalized healthcare. We’re bringing those together with the power of Roche Diagnostics to really be able to identify disease and use data to understand how medicine can help in a better way. I think our growth will be in combining all the different aspects together as one Roche to really have a greater impact on society.

CW: We’ve heard from all the companies we interview that the pandemic continues to create operational challenges. What are Genentech’s biggest challenges here in California?

AG: It’s the variability the pandemic has created. People weren’t going to the doctor and new patients weren’t being diagnosed. That created variability in demand. But there’s also variability in supply. We have to source thousands of different materials to be able to make our medicines. Variability across global supply chains for raw materials and other items definitely has created some challenges.

Processing valve array. This array is controlled by a software program and helps create a flow path for a specific process to manufacture a specific drug. Oceanside, CA.

CW: Have you identified any opportunities in the current environment?

AG: I talked earlier about really having to look at how we can squeeze every little gram we can out of our manufacturing facilities. That comes by really looking at your processes. I think our current opportunities really have to do with radically simplifying and getting down to doing those things that truly add value while getting rid of every tiny bit of waste that we can. How are we standardizing? How are we using digitization? How can we use lean manufacturing in order to really increase our efficiency, our speed, and the robustness of our processes?

CW: I understand that Genentech is currently building a clinical supply center in South San Francisco. Does the company plan to add more jobs to the California economy?

AG: We’ve had a presence in California for 45 years now. In that time, we’ve continued to invest and grow the company. Genentech’s South San Francisco headquarters is also the headquarters for Roche biotech in the United States. And if you look at our track record of the investments we continue to make — not just in the South San Francisco campus but in R&D and the footprint we have there as well as our other manufacturing facilities — we’ll continue to be a leader for California in terms of job growth.

A harvest filtration unit used to separate biologic medicine from cell debris. Each unit contains filters and the machines work in sequence in the separation process. This unit was built circa 1985 and was one of the first large scale manufacturing tangential flow filtration units in the world. South San Francisco, CA.

CW: What do you see as Genentech’s needs in relation to this future?

AG: When I started at Genentech in 1995, we were the founders of biotechnology. As years have gone on, there have been more players, tons of startups, and it [has become] a super exciting industry to be a part of. Every day you read an article about a new modality or a new way to potentially treat a disease.

We need to continue to have California be a place that talent wants to be. We work really hard to build relationships with universities and to invest in our communities. We invest in STEM education and really getting kids excited about science and the impact they can have on the world. I think we need to continue to make California a place for opportunity, innovation, excellence, and growth.