It’s one thing to create a vaccine formula that the world is crying out for; it’s quite another to get it into billions of arms. Commensurate with the challenge, German biotech firm CureVac provides a case study in how a rising star in vaccine development is ramping up production to meet virtually infinite demand.
When the COVID-19 pandemic broke out, CureVac immediately applied the messenger RNA (mRNA) technology its founder, Ingmar Hoerr, had pioneered more than 20 years ago, to develop a vaccine candidate. Currently in the process of completing its late-stage clinical trials, the company expects approval to produce and distribute its vaccine in the second quarter of this year. Two other mRNA vaccines are already in circulation.
Ramping Up Operations in All Areas
CureVac therefore needs to rapidly transition from research and lab-scale producer to large-scale manufacturer. CEO Dr. Franz-Werner Haas recently announced the goal of producing 300 million doses by the end of this year and 600 million in 2022.
Pierre Kemula, chief financial officer of CureVac, described the challenge ahead: “To get ready, we have to ramp up our operations in all areas, including manufacturing, procurement and supply chain, quality management, business planning, and analytics – but also administrative functions like human resources and finance.”
Video by Tilman Goettke and Klaus Boeckle
To scale up rapidly, CureVac is working with partners. In January, the company entered a collaboration and services agreement German multinational pharmaceutical group Bayer to draw on its expertise and infrastructure. Then in February, CureVac announced a collaboration with GSK, building on their existing relationship to jointly develop next-generation mRNA vaccines to address multiple emerging variants.
By developing a broad and integrated European vaccine manufacturing network with experienced contract development and manufacturing organizations (CDMOs), CureVac will tap into expertise and capacity across Germany, France, the Netherlands, Belgium, Spain, and Austria, as well as potentially Sweden, Poland, Italy, and Ireland. CureVac is also building a large-scale production facility at its headquarters in Tübingen, to go into operation in 2022.
Although mRNA vaccines are not a new concept, the pandemic marks the first time they have been authorized for use outside of clinical trials. The resulting surge in demand has been the source of some hiccups in the supply chain. A shortage of messenger RNA is not expected, but there is already a scarcity of other materials needed to produce the vaccine, according to Scientific American.
One of the limiting factors in vaccine production currently are lipid nanoparticles (LNP), the material needed to encapsulate and protect the messenger RNA, which are very sensitive and require rare special expertise to produce, explained Dr. Oliver Nürnberg, chief product owner for SAP Life Sciences at SAP.
Moving the Needle: CureVac Entrusts SAP with its Business Transformation
A business transformation of this magnitude with peak demand and supply chain challenges from the outset requires a highly adaptable, integrated, and intelligent enterprise resource planning (ERP) system. To achieve the desired scale quickly, CureVac will focus on developing and producing vaccines, while relying on SAP S/4HANA Cloud for its business and operations.
“We need a partner like SAP to define and implement the business processes to tackle this incredible growth,” Kemula confirmed. CureVac leaders have teamed up with SAP to introduce cloud-based solutions for procurement, manufacturing, quality management, and supply chain processes to a global scale.
Since most of CureVac’s partners, suppliers, and customers already run SAP, CureVac’s CFO is convinced the collaboration, sharing of digitized data or interoperability of manufacturing and supply chain systems will be much easier. “SAP solutions also support CureVac’s GxP compliance, which is a key requirement for all biopharmaceutical companies. This a must-have for us,” he said.
Top image via video.
