In 2021, at the height of the COVID-19 pandemic, the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) developed a pandemic preparedness plan for future outbreaks and established the Center for Pandemic Vaccines and Therapeutics (Zentrum für Pandemie-Impfstoffe und -Therapeutika, ZEPAI). ZEPAI then sought partners for this massive undertaking.
The experience with scarce COVID-19 vaccines led to the government’s decision to secure production in Germany itself. Pharmaceutical producers that had appropriate vaccine expertise and capacity were invited to apply for pandemic-preparedness contracts. Wacker Biotech and CordenPharma, which together cover the entire production chain for mRNA vaccines, joined forces to do precisely that. The companies, alongside four other companies, were awarded a contract in April 2022.
CordenPharma has in-depth expertise in the GMP manufacturing of specialized lipids, lipid nanoparticles, and injectable drug products. For example, the company was a key lipids manufacturer for COVID-19 mRNA vaccines. Wacker Biotech, a fully owned subsidiary of Wacker Chemie (WACKER), has become a specialist in therapeutic proteins, living biotherapeutic products, plasmid DNA, and conventional vaccines based on microbial systems. It was one of the first companies to address the production of mRNA vaccines.
Together, the companies cover the complete vaccine production pipeline. In the event of a new pandemic, the government will need to select a suitable vaccine and arrange for it to be produced in large amounts to protect the population. To ensure vaccine supply, the government will call upon the companies to coordinate their development and production efforts.
Meeting a tight deadline
It was a Herculean task to achieve pandemic readiness in the allotted time: just two years. The contract required expanding the companies’ facilities to enable annual production of 80 million vaccine units. Since the COVID-19 pandemic revealed the vulnerabilities in global supply chains and the need to reduce such dependencies, the contract stipulated that all critical manufacturing steps had to take place in Germany, and that all production steps had to take place in the European Union. On June 1, 2024, this goal was met when the companies officially entered a state of pandemic readiness. Two days later, Wacker Biotech opened its new mRNA competence center alongside its existing facility at the Weinberg Campus Technology Park in Halle.
To help achieve everything by the two-year deadline, it was necessary to plan and erect a new building, obtain the requisite equipment, and take on and train considerably more staff. To make it possible for mRNA vaccines to be produced in huge quantities if needed, the new building in Halle includes four production lines for biopharmaceuticals—quadrupling Wacker Biotech’s previous capacity. Everything at Halle is under control: time management, adjustment of schedules, and coordination of and communication with partners, service providers, and ZEPAI. As the central process steps take place in Halle, the site is central to the pandemic preparedness project.
For its part, CordenPharma launched two major expansion projects: Increasing the size of the lipid production area to produce the necessary quantities, and investing in supercritical fluid chromatography, a green purification technology for compound separation that does not use organic solvents. CordenPharma also expanded its existing fill and finish capacity so that it would be able to supply the required number of vaccine doses in a relatively short period of time.
Ensuring flexibility and readiness
To ensure maximum flexibility at Halle, we rely on what is known as the “ballroom concept.” Building the new facility included planning for maximum flexibility. Under this model, everything is designed to be as variable and modular as possible, making it particularly easy to move equipment between rooms as needed. There are also no permanent piping systems in the production facilities. We are trying to represent a cross-section of the technologies that are most likely to be needed.
Wacker Biotech and CordenPharma have likewise adopted the notion of a “warm base,” where production facilities and staff are in a state of constant readiness to be deployed instantly. The necessary starting and auxiliary materials are on hand as well. The intersite logistics strategies, too, can be implemented immediately. If the German government gives the order to produce mRNA vaccines, we switch over to pandemic mode and can start the production process shortly after.
The permanent pandemic preparedness strategy put into effect here also benefits our customers. This makes us very flexible, enabling us to implement customer projects rapidly and with a high degree of supply security.
The process technology required for industrial-scale mRNA vaccine production was built up at Wacker Biotech’s Amsterdam site. That effort laid the groundwork not only for our pandemic preparedness plan but also for setting up the mRNA competence center in Halle. To date, WACKER has invested more than 100 million euros in this expansion project, with the plan to spend an annual average of about $88 million (€80 million) on its biotechnology operations.
Beyond the technology building, we needed sophisticated strategies for human resources, production planning, and stock keeping. We currently use at least 50% of our capacity for customer projects, while the other half is reserved as standby capacity for vaccine production, for which we are compensated by the German government. Because our production sites need a good mix of projects that make it easier for us to move something from A to B, we are continuing to set up redundant production lines.
Stock keeping is of equal importance for the pandemic project. All the raw
materials, such as chemicals, enzymes, and single-use systems (that is, filters or plastic bags), must be present, which required us to design a special storage and monitoring system so that stocks can always be kept “fresh.”
As a contract development and manufacturing organization, Wacker Biotech is used to rapidly switching from one customer project to another, which includes adeptly moving to different production processes. This flexibility involves not just the manufacturing stage, but also the process development, management, and engineering stages, all of which precede the manufacturing stage.
An equally state-of-the-art approach was adopted when it came to recruiting and training new staff. Because we had to take on a lot of staff in a very short period of time, we put significant effort into recruiting highly talented personnel. Because we cover the entire value creation chain, we need to recruit employees from different disciplines, such as chemical and pharmaceutical technicians, IT specialists, and quality managers. We involved new employees in ongoing production at other corporate units, and we set up dedicated training rooms so that new staff members could learn how to operate the various pieces of equipment needed for their work. If a particular piece of equipment was not yet physically available, we used virtual reality modules to make the most of the familiarization phase.
Keeping the public and customers in mind
We benefited from being directly involved with our own customer projects at the start of mRNA vaccine development. Our COVID-19 pandemic production of a clinical mRNA candidate vaccine in particular gave us invaluable experience.
Assiduous planning and flexibility were the factors critical to the project’s success. Focusing on these factors enabled us to move at a rapid pace, engage in parallel ramp-up efforts, and devise innovative solutions that will benefit customers well into the future as well as prepare us to respond rapidly to the next pandemic.
Andreas Anton, PhD, is senior project leader, pandemic preparedness at Wacker Biotech.
