Vaccine for the entire world

It was 20 years ago that a doctoral student at a laboratory at the German University of Tübingen stumbled upon an unexpected phenomenon. Searching for new vaccine substances, the biologist injected mice with liposome-encapsulated RNA samples, which contain instructions for the manufacture of proteins. The body ought to recognise the protein produced by the cells as a foreign substance and trigger a defensive response. After injecting unencapsulated RNA into a control group, the young student made a surprising discovery: against all expectations, the bare RNA without a protective liposome coating triggered a strong immune response.

The young researcher at the University of Tübingen was Dr Ingmar Hoerr. One year after his serendipitous discovery, together with fellow students Dr Florian von der Mülbe and Dr Steve Pascolo and his professors Dr Hans-Georg Rammensee and Dr Günther Jung, Ingmar Hoerr founded CureVac, a company that specialised in the research and development of innovative pharmaceuticals based on messenger RNA (mRNA). The idea was that if researchers could find a way to stabilise the new method, the human body would be in a position to manufacture its own medications and vaccines. Ingmar Hoerr and his co-founders fought long and hard for the technology, as few in the industry recognised its potential. It wasn’t until the coronavirus pandemic that a breakthrough was finally achieved. The technology is the foundation of the company’s promising vaccine against COVID-19.

Production of the vaccine is currently in high gear at Tübingen-based CureVac. A clinical phase 3 study was launched in December 2020. Assuming the results are successful, approval is expected in the second quarter of 2021. Although other companies brought their candidates to market earlier, speed is not everything. The CureVac vaccine is easier to handle. According to initial data, it can be stored for up to three months at refrigerator temperatures. That means people in difficult-to-access regions can be vaccinated, an important advantage in efforts to ward off the virus in every corner of the world.

CureVac also differs from other manufacturers in yet another way: “The company developed the end-to-end production process itself and manufactures the vaccine partially in its own plants,” said Philipp Garbers, Industry Manager Life Sciences at Endress+Hauser Germany. In 2019 the authorities had already certified the world’s first GMP-compliant system for the manufacture of mRNA therapeutics at CureVac and granted approval for the production of clinical trial samples. The process is standardised and universal. All therapeutics can be manufactured on the same production platform, thus leading to faster availability of the new mRNA pharmaceutical.

As a full-service supplier, Endress+Hauser was CureVac’s partner of choice for the measurement instrumentation and is currently helping the company to rapidly expand its production capacity. Another, even larger plant is being built on the Tübingen campus, which is scheduled to go into operation in 2022 with an estimated capacity of billions of vaccine doses annually.

“Standardisation of the instrumentation was important to CureVac as a way to simplify the work of the production workforce,” Garbers said.

The company also profits from Endress+Hauser’s industry knowledge and calibration expertise.

“In the pharmaceutical industry, the initial calibration of critical measuring points must be performed onsite in the qualification phase of new plants,” Garbers explained. “Endress+Hauser is one of the few companies in Germany with the capability to carry out these types of calibrations onsite for a wide range of parameters.”

CureVac’s proprietary technology is based on using chemically unmodified RNA as a medium to instruct the body on how to produce its own correspondingly encoded proteins to combat a wide range of diseases. With this technology as a foundation, the company has established a clinical pipeline in the areas of prophylactic vaccines, cancer therapies, antibody therapies and the treatment of rare diseases. CureVac now employs more than 600 people at its locations in Tübingen and Frankfurt (Germany) and Boston, Massachusetts (USA).

Image: CureVac (www.curevac.com/en)