Long before the world learned about the global health threat of COVID-19, the everyday heroes behind the scenes at Roche knew the gravity of their mission. Cancer patients depend on them for treatments. Those with autoimmune diseases, heart disease and other rare diseases do, too.
Clinical development and ongoing trials cannot just stop. Diagnostic tests are steadily needed and must be shipped all across the globe. Around the world, healthcare communities and patients depend on deliveries of Roche solutions – every day, and even more during a pandemic.
So they left their families and worked long shifts, day after day. Leaders from engineering volunteered overnight in warehouses to keep things moving 24/7. Some employees lived onsite because border crossings were uncertain or delayed if they go home. These were the everyday heroes behind the scenes at Roche.
Pushing technology to its limits while personally battling COVID-19
Making antibody medicines is a very complex and time-consuming process. Making medicines during a pandemic — where speed and safety is paramount — greatly compounds the process. So when the teams at the Roche Drug Substance facility in Vacaville, USA, were enlisted to help in the fight against COVID-19 by manufacturing potential life-saving medicines, the initial reaction was excitement. However, the team very quickly faced a herculean challenge: ensuring Roche had the technologies and capabilities required to manufacture this therapy at scale and as quickly as possible.
Completing a drug substance (the active ingredients that give a medicine its efficacy) product transfer, “tech transfer”, typically takes anywhere from 9-12 months. So when the directive came through that this process was to be completed in around 15 weeks, everyone’s jaws dropped.
“It was at this time that I personally caught COVID-19. It was the worst possible time. Many initial activities, including establishing site teams and objectives, were ongoing and I felt I was letting my team down right at the start of such an important project.” says Keith, a Tech Transfer Specialist at the Roche manufacturing facility in Vacaville.
Keith however was even more motivated by his own experiences. “It gave me a real passion and dedication to help ensure people didn’t need to go through what I had gone through,” he says. Having this level of passion was critical to the team’s success, but passion and dedication alone weren’t enough. Such a bold timeline required a completely new way of working, coming in on weekends and holidays, and stepping outside of comfort zones.
An example of this was the approach to conducting sample studies of the drug substance. These studies are part of every transfer of a clinical product to manufacturing at large scale and are designed to help ensure the safety and efficacy of a medicine. Traditionally, most of these studies are conducted prior to a transfer, yet the dire urgency for this medicine required a rethink of the study process.
To ensure speed and safeguard the proposed timeline, the sample studies had to take place in parallel to many other processes ramping up to manufacturing. Beyond this, the comparative novelty of this medicine made using historical sample study and manufacturing process data all the more complex. This meant that an overwhelming amount, approximately 700 studies, were needed to fully guarantee the efficacy and safety of this medicine; far more than the 200 studies usually conducted.
Only by partnering with the Quality Control teams and creating new and streamlined processes to manage, collect, and ship these studies to the relevant teams did this become possible. By building a process that ensured accurate information reached those that needed it as quickly as possible - and decisions could be taken instantly - were the teams able to deal with 700 samples AND safeguard the tech transfer timelines.
“It was with this kind of novel teamwork and the openness to embrace new ways of working that we achieved what our team had initially thought impossible: To do what usually takes 9 months in just 123 days! I couldn’t be prouder of our team”, Keith concludes with a smile.
At first glance, the Penzberg plant appears abandoned. But in some parts of the buildings, there is a hustle and bustle, with employees working at incredible speed. The facilities at Diagnostics Operations Penzberg (DOZ) produce ingredients and reagents that help in the fight against COVID-19. Markus works as a laboratory chemist in the production at DOZ in Penzberg and is dedicated to keeping things running smoothly.
"Patients all over the world depend on our products. Many of the critical materials that have helped in detecting novel coronavirus come out of Penzberg, explains Markus. “With our work we have been helping to ensure that patients and entire societies can properly evaluate and take measures to stop the spread,” he says.
When countries around the globe were struggling with supplies that assist in fighting and detecting the virus, the immense pressure to produce while also keeping the team healthy was not lost on Markus. "Demand was constantly increasing. In order to meet the needs, we produced 24 hours a day, seven days a week. In general, we also depend on some external factors such as obtaining all the necessary raw materials in sufficient quantities and coordinating the filling process in such a way that our colleagues can manage it,” he says.
Because the team is highly trained, they also had taken precautionary measures to ensure that not even the coronavirus itself would stop them producing these desperately needed supplies. Markus explains that “in order to protect ourselves and stay safe, we separated colleagues working on our floor into different groups. Those groups were not allowed to physically meet. Other colleagues were working from home and we communicated via Hangouts." It was unchartered territory for the team, but there was no shortage of motivation and passion to continue their mission.
"Working from home so much felt a little strange for me," says Niels Bauer, a straight-talking foreman in Pharma Operations Packaging in Mannheim. "Usually, I'm always in the middle of things."
But the pandemic had its own plans for people working in Pharma Operations. One drug that Niels and his colleagues pack in Mannheim is in a global clinical trial. Demand for the medicine grew rapidly in other countries, such as Italy and the team had to prepare 20,000 vials for Italy in less than a day.
“‘The packaging arrived. The truck is coming tomorrow. When can you start?’ they asked,” Niels says. “Then the whole chain simply has to work perfectly in order to bring the product on the truck on time."
Everyone in the team knows that if a product is missing, people could die. At the same time, other products must continue to flow. So Pharma Operations ramped up production.
"We all moved in the same direction, passing the ball flexibly while running, and the solutions were pragmatic – despite the much larger order volume," Niels says.
“The dynamics were demanding, but this makes us a great team. The patient may be rather far away from us, but the thought that a drug would become scarce and thus endanger patient care is a great motivation – every day anew."
A clean work environment is important for a large campus with thousands of employees to prevent the spread of germs such as COVID-19. And in some parts of Roche, such as labs and manufacturing areas, hand sanitiser is critical to maintaining a germ-free environment to conduct experiments and produce medicines for patients around the world.
As reports of hand sanitiser shortages spread across the globe, teams at Roche rolled up their sleeves and took initiative.
To help ensure a healthy environment for those who continued to work on site at Roche headquarters in and around Basel, Switzerland – and assist the greater community by reducing the spread of germs while still making medicines – the Global Technical Development Synthetic Molecules scientists and Basel safety, security, health and environmental group teamed up to make “homemade” disinfectant.
“The team was thinking of the community, acting with urgency and prioritising work quickly”, says Dharmendra SinghalI, Head Technical Development, Small Molecules at Roche. “They were helping keep business-critical employees safe on site so we could continue to serve our patients.”
The group manufactured 1000 liters of disinfectant in one day and distributed it to the Basel and Kaiseraugst sites. To meet demand, the team ramped up to 4000 liters a week in an effort to make enough for its employees who continue to work round-the-clock to help patients with medicines and testing solutions.
“Keep on sanitising your hands!” says Dharmendra. “I can’t think of a better example of changing a manufacturing schedule on such short notice to quickly fit this in – it’s an example of working together and making it happen.”
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