A manufacturing operator preparing buffer

安全,焦点和目的感

Pharma技术运营的致力于为患者提供深刻的承诺bob投注平台

Published 30 July 2020

在最佳情况下,使生物学是复杂且耗时的。但在大流行中,Roche Pharma全球技术运营团队正在比以往更快地进行,以确保目前和未来为患者提供药品。bob投注平台

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.

蒂姆布朗那Vice President and General Manager, Genentech Hillsboro
蒂姆布朗那Vice President and General Manager, Genentech Hillsboro

3月中旬,许多国家正在锁上持续扩大的大流行。与此同时,世界各地的罗氏制药技术运营团队正在升级。目标?继续为那些依赖于他们的人提供所需的药物,同时也尽可能多地制作药物,以帮助稍后可能需要它的人。

Safety

“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.”

3月13日,一个请求进入了山区Genentech“填写”设施的团队,其中液体生物药物从大批转移到较小的小瓶中,然后标记,包装并准备用于全球运输。

Genentech fill and finish facility in Hillsboro, Oregon
Genentech在俄勒冈州Hillsboro的设施

团队可以做技术转移吗?这是转移技能,知识,技术和制造特定产品和从一个制造部位的方法的精确过程。它需要令人难以置信的规划,重视细节和协调,以确保生产可以在相同的严格参数,控制和质量系统下从一个站点转移到另一个站点,全部监管批准。此举是为了确保可能需要它们的患者可提供足够的药物。bob投注平台

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."
蒂姆布朗Vice President and General Manager, Genentech Hillsboro

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设施是无菌的,并且微生物控制对于维持员工在员工在细胞或药物附近工作的地区来说至关重要。“GOONNING”,员工DON脚趾个人防护装备的过程是保护生产环境和产品的标准程序。但在Covid-19的时候,它也有助于保护员工。

Focus

随着现场协议和新的Covid-19安全措施,是时候专注于手头的任务了。前所未有的情况需要创新的思考和大胆的新想法,这正是团队所做的。

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.”

在视觉上检查样品的员工
在视觉检查站“Gowning”的员工。样品的目视检查是在俄勒冈州Hillsboro的Genentech US现场监测缺陷。照片由David Vergne

Empower

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?”

如果你赋予人们,建立合适的团队做出决定,并给予他们的护卫队以最有效和最有效的方式开展工作,这是我们人民可以做的惊人。“
蒂姆布朗Vice President and General Manager, Genentech Hillsboro

敏捷

有一些员工在家庭和基本员工工作,他们使用像格雷罗板和jamboard等虚拟,交互式协作工具,以跟踪行动和决定。他们与其他全球网站进行了咨询过,从过去的经验中攻击了这些数字,应用了自己的经验,比较了差距和效率,向前迈进了。

High-speed automated packaging
High-speed automated packaging operation. Biologic medicines are packaged at these stations before delivery. Hillsboro, Oregon. Photo by David Vergne

“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.”

另一个挑战?一旦药物准备就绪,只有几种航班就可以让他们在美国内部的目的地和世界各地的其他地方。再次,合作至关重要,Roche供应链专家帮助团队跟踪和目标特定航班。

“一切都必须排队,”蒂姆说。“我们的生产人员不能错过击败。当我们停止生产计划释放和运输时,它通常需要大约90天。我们在22天完成它。我们在确切的一天生产,因为第二天产品必须在飞机上。这是唯一可用的飞机。“

Purpose

通过锁定,社会疏散,不确定性,家庭教育和杂货店货架上的短缺,团队在3月中旬至7月的七天,七天的班次工作。没有人抱怨。最后,在7月4日假期,他们休息一下。

“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.

Tags:ScienceClinical trials