More than a year into the coronavirus pandemic, the world’s attention is firmly set on vaccines as a near-certain way out of crippling lockdowns.
Vaccine manufacturers have found themselves at this new front in the battle against COVID-19, bolstering plants and processes to meet the massive demand for life-saving doses.
German chemical firm Wacker has been making vaccines at its Amsterdam site for more than 20 years. It recently invested around €50m in its Zuidoost plant, and it can now produce large volumes of mRNA-based vaccines, the type created by Pfizer-BioNTech and Moderna, and an upcoming vaccine by CureVac in Germany.
Dr Jörg Lindemann is managing director of Wacker Biotech’s Amsterdam site. He told I amsterdam how the firm has geared up to produce vaccines on a super-sized scale, and how Amsterdam’s abundance of expertise and strong life sciences ecosystem makes the city a great place to invest and collaborate
How was the start of 2020 for Wacker Biotech, compared with the end, in terms of business focus and purpose? How did things change over the course of the pandemic?
2020 was a very eventful year for Wacker Biotech. We began by setting up a new production line at the Amsterdam site and procuring new equipment. At the same time, we also invested in modernisation projects that laid the foundation for future production of mRNA-based vaccines in new cleanrooms.
Our activities here have taken a dynamic turn over the past few months since signing an initial agreement with CureVac. We’ve certainly got our hands full, especially when it comes to the challenges posed by the coronavirus and the pandemic.
What were the main challenges and what were your successes?
We set up a new production line for mRNA-based vaccines and are currently working to transfer the production process for CureVac’s CVnCoV vaccine candidate. Something like that would normally take up to one year, but over the past few months, we’ve pulled out all the stops in order to accelerate that process. We’ve also modified our expansion project to make that happen. We’re making good progress right now. We never would have been able to pull it off without the dedication of our employees here on site and of our internal and external partners.
How is Wacker Biotech involved in the production of Covid-19 vaccines?
Our current plans are to produce the mRNA drug substance for CureVac’s coronavirus vaccine (CVnCoV) in our capacity as a contract manufacturer.
How many vaccines do you aim to produce?
We’re planning to manufacture numerous drug substance batches which will translate to 100 million doses of the CureVac vaccine per year at the Amsterdam site once the vaccine has been approved.
What makes Amsterdam a good location for vaccine production? How has the site been preparing for that?
Amsterdam is a great location with a lot of talented people and has a well established infrastructure. The Wacker Biotech site in Amsterdam has been making vaccines as a contract manufacturer for over 20 years and has expertise in the field. In recent months, we’ve laid the groundwork for manufacturing new gene-based vaccines, such as CureVac’s mRNA-based vaccine. Here in Amsterdam we have the expertise, the right environment and the prerequisites for manufacturing that kind of vaccine quickly.
What’s key to scaling your production now?
We’re still looking for specialists to join our team despite the brisk pace of our recruiting efforts. Over the course of producing CureVac’s vaccine, we will be creating roughly 50 additional jobs. We’re mostly looking for employees in Production, Quality Control and Quality Assurance, along with technical and logistical support personnel.
Why is it important to get a vaccine out to market quickly and how does Wacker Biotech facilitate this process?
The faster a vaccine can be brought to market, the faster it can protect from infection. As a contract manufacturer, we support our customers with the full development chain. From early development work serving preclinical studies over to clinical GMP manufacturing and later - after approval - we are able to commercially manufacture the vaccines for the market.
What are the potential hurdles for vaccine production?
There are different types of vaccines, and the processes for manufacturing them are as diverse as the vaccines themselves. For a conventional vaccine, for example, production begins in what are known as fermenters, where bacteria copy and produce the desired active agent, which then undergoes multiple purification steps. The process is very complicated and subject to strict regulations.
How do new variants of COVID-19 affect production?
We might end up having to adjust the mRNA “cocktail”; that discussion is currently underway both in public and among the companies putting vaccines into circulation. The authorities will then review those adjustments through an accelerated approval process.
What’s the process for adjusting a vaccine based on a new variant? How quickly can that happen?
We don’t expect the process of adapting mRNA-based vaccines for SARS-CoV-2 to take long, since it would probably mean adding another mRNA for, say, the modified spike protein. The change would then go back through what would likely be an accelerated approval process with the European Medicines Agency (EMA).
What are Wacker Biotech’s goals for 2021 in terms of COVID-19 vaccine production and business-as-usual work?
We aim to launch GMP production of CureVac’s CVnCoV vaccine during the first half of 2021 so we can help improve vaccine supplies the best we can. At the same time, we’ll continue producing other – conventional – vaccines on site. Because these use different facilities, we are able to produce the vaccines in parallel.
How does Wacker Biotech connect to and collaborate with Amsterdam’s life sciences and health sector?
Development in the life sciences and health sector in Amsterdam has been very positive. A lot of companies – startups too – have located here in recent years in places like I Quarters in the Life Sciences District. We rented offices there last year as well, because we needed the extra space. I’m confident we’re going to see a lively exchange of ideas there, possibly even the development of cooperative ventures. We also value the support Amsterdam’s local representatives provide the sector.
How has the arrival of the EMA in Amsterdam changed/benefited your work and collaborations?
We work closely with the Dutch public health inspection agency (IGJ). The authorities regularly review and inspect our plants and production facilities for compliance with regulations. Our physical proximity to the EMA is also very helpful when it comes to obtaining approval for our customers’ products. Customers who have appointments with the EMA can easily combine these with a visit to our Amsterdam site. That’s a real advantage of our location.