Making biologics is complicated and time-consuming under the best circumstances. But in the midst of a pandemic, Roche Pharma Global Technical Operations teams are doing it faster than ever to ensure medicines are available for patients now and in the future.
The process of persuading live cells to produce biological medicine is exacting and highly technical. In simplest terms, think of biotech manufacturing plants as precision “farms” that grow cells, and those cells are trillions of tiny farmers that help produce biological medicines.
Most biologics are based on very large, complex proteins produced by cells. Because the cells are living, each one needs careful tending, a sterile environment and constant monitoring, with strict documentation under government regulatory rules. In contrast, small molecule medicines – like a pill you might take for a headache – are typically manufactured by combining specific ingredients at specific times, in a process of chemical synthesis.
In mid-March, many countries were going under lockdown in response to the ever-widening pandemic. Meanwhile, Roche Pharma Technical Operations teams around the world were ramping up. The goal? Continue to supply needed medicines for those who rely on them, while also making as much medicine as possible to help those who might need it later on.
“In those first days, we weren't even sure if we'd have enough hand sanitizer, so to keep the production floor running was incredible,” says Tim Brown, Vice President and General Manager at the Genentech Hillsboro, Oregon site. “But we didn't skip a beat. In fact, we've had the best performance at the site over these last four months that we've ever had.”
On March 13, a request came in to the team at the Genentech “fill and finish” facility in Hillsboro, where liquid biologic medicines are transferred from large batches into smaller vials, then labeled, packed and prepared for shipping across the globe.
Could the team do a tech transfer? That’s the precise process of transferring skill, knowledge, technologies and methods for producing specific products and processes from one manufacturing site to another. It takes an incredible amount of planning, attention to detail and coordination to ensure that the production can be transferred from one site to another under the same rigorous parameters, controls and quality systems, all under regulatory approval. The move was to make sure enough medicines would be available for patients who might need them.
That same week, the governor of Oregon mandated work-from-home orders for all but essential personnel. With about a third of the Hillsboro workforce working remotely, and social distancing measures being rolled out on site, it came down to priorities: “keep our people safe and supply medicines to patients,” Tim says.
Biotech facilities are sterile, and microbial control is critical to maintain a cleanroom environment in areas where employees work near cells or medicines. “Gowning,” a process where employees don head-to-toe personal protective equipment, is standard procedure to protect the production environment and the product. But in times of COVID-19, it was also a benefit to help protect employees.
With existing site protocol and new COVID-19 safety measures in place, it was time to focus on the task at hand. Unprecedented situations require innovative thinking and bold new ideas, and that’s exactly what the team did.
A tech transfer normally takes 12 to 18 months. Hillsboro did it in four weeks without compromising on quality or safety. Tim says the secret to being quick and nimble is giving teams clear focus, singular goals and the power to make decisions.
“We made this our No. 1 priority for the site, and we stopped many other things,” Tim says. “We typically work on many projects and initiatives at once. But when we really focus on one important thing, we can get it done in record time.”
The Genentech site organized four squads to work on the tech transfer. In normal times, everyone reports up through a multi-layered governance structure. In this circumstance, each squad made decisions to move the project forward. They also took a new approach, using collaboration with Roche global teams and eight years of production experience to create a new plan and accomplish the same tasks, to the same exacting standards, in record time.
“We asked: ‘What can we actually get done in those four weeks, versus following the steps that take 12 to 18 months?’” Tim says. “If the plan says 12 to 18 months, guess what? It takes 12 to 18 months. But if you break it down, what do I really need to do?”
With some employees working from home and essential employees onsite, they used virtual, interactive collaboration tools like Trello boards and Jamboard to track actions and decisions. They consulted with other global sites, crunched the numbers from past experiences, applied their own experience, compared the gaps and efficiencies, and moved forward.
“By thinking outside of the box, we came out with an innovative way of doing the transfer,” Tim says. “It was an amazing achievement for all of Pharma Technical Operations, because it took collaboration from everyone to support us and achieve this goal.”
Another challenge? Once the medicines were ready, only a few flights were available to get them to their destinations within the US and to other locations around the world. Once again, collaboration was crucial, and Roche supply chain experts helped the team track and target specific flights.
“Everything had to line up,” Tim says. “Our production folks couldn't miss a beat. It normally takes about 90 days from when we stop production planning to releasing and shipping. We were getting it done in 22 days. We produced to the exact day, because the product had to be on the plane the next day. It was the only plane available.”
Through lockdown, social distancing, uncertainty, home schooling and shortages on grocery store shelves, the team worked nonstop, in shifts, seven days a week, from mid-March to July. Nobody complained. Finally, over the July 4 holiday, they took a short break.
“I talked with a few team members recently and one thing I heard really resonated,” Tim says. “It’s been the most rewarding six months of my career, and they felt the same. They're so proud of the achievements they made and the impact of their work. There is an amazing sense of purpose not just at this site, but across the whole of Pharma Technical Operations. We know we can make a difference for patients, for society.”
Roche and Genentech, a member of the Roche Group, operate 15 Pharma Technical Operations production and manufacturing plants at 11 sites in Switzerland, Germany, Singapore, China, Brazil and the US, including South San Francisco, Vacaville and Oceanside in California, and in Hillsboro, Oregon.