Published 30 July 2020
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.
大多数生物是基于非常大,复杂的公关oteins 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 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.”
Three things were key; the safety of our people, intense focus on priorities, and our commitment to supply medicines for patients now and in the future."
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.
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?”
“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.”
“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.”
罗氏Pharma Technical Operations
罗氏公司基因泰克,罗氏集团的一员,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.