Full Press Release Details
CureVac and Rentschler Biopharma
Ramp up for Joint Manufacturing of COVID-19 Vaccine, CVnCoV
Germany and Boston/Milford, MA, USA, February 1, 2021 - CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company
developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Rentschler Biopharma SE, a leading
global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced today that the companies have
initiated the set-up of manufacturing capabilities for CureVac s COVID-19 vaccine, CVnCoV.
Rentschler Biopharma is gearing up for
largescale cGMP (Current Good Manufacturing Practice) production of the formulated mRNA for CVnCoV. CureVac has started the clinical
Phase 2b/3 trial with its mRNA-based vaccine candidate against SARS-CoV-2, and therefore, is preparing the start of commercial
production to meet global demands. Rentschler Biopharma contributes to the manufacturing of active pharmaceutical ingredient, downstream
processing and formulation of drug substance for the vaccine.
The companies entered into a collaboration
in November 2020 with the set-up of dedicated production lines at the Rentschler Biopharma site in Laupheim, Germany. Currently,
optimization of the production process is taking place to increase mRNA yield. It is expected to produce more than 100 million
doses of the CureVac vaccine per year in Laupheim.
Dr. Florian von der M lbe, Chief Production
Officer of CureVac, said: "We are pleased to partner with Rentschler Biopharma, whose quality work is well known in the industry,
to conduct key aspects of the CVnCoV production process. CureVac has started building an integrated European vaccine manufacturing
network with several CDMO partners. With this strategy, the company will expect a significant increase in manufacturing capacity
for CVnCoV, potentially reaching up to several hundred million doses per year while mitigating potential supply chain risks."
Dr. Frank Mathias, CEO of Rentschler Biopharma,
said: "Rentschler Biopharma has extensive experience in working with the most complex biopharmaceuticals and our expert team
is dedicated to meeting CureVac's high expectations in producing their mRNA vaccine against COVID-19. We are preparing now
to be ready to manufacture commercial supply, and are already setting up the production suite. We are currently looking to hire
up to 80 highly qualified new team members, such as lab technicians and bioprocess engineers, to contribute to this important project
and help us satisfy the increasing demand for life-saving biopharmaceuticals in the long-term."
Federico Pollano, Senior Vice President
Global Business Development of Rentschler Biopharma, added: "From the beginning of our planning process, the relationship
between the CureVac and Rentschler Biopharma teams has been highly collaborative, driven by our common goal of doing our part to
address the major global need for safe and effective vaccines against COVID-19. We are working tirelessly to optimize the production
chain and then obtain the necessary regulatory certifications, so that we can begin manufacturing large-scale commercial supply
as soon as possible."
CureVac began development of its mRNA-based
COVID-19 vaccine candidate in January 2020. The vaccine is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized
full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nano Particles (LNPs). Phase 1 and 2a clinical trials
of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was
generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell
activation. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response
after natural COVID-19 infection. The data supported CureVac's decision to advance a 12 g dose into its current pivotal
Phase 2b/3 study, the HERALD study, which started in December 2020. Clinical trial material is provided by the company's
substantial production capacities for mRNA vaccines at its headquarters in T bingen, supported by the current expansion of
manufacturing capacities in Europe, allowing broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
CureVac is a global biopharmaceutical company
in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile
biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified
mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based
on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer
therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq
in August 2020. It is headquartered in T bingen, Germany, and employs more than 500 people at its sites in T bingen,
Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
About Rentschler Biopharma SE
Biopharma is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. From
its headquarters in Laupheim, Germany and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing
of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler
Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level
quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality
and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the
biopharmaceutical value chain, the company has entered into a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned
company with about 1,000 employees. For further information, please visit www.rentschler-biopharma.com.
Follow Rentschler Biopharma on LinkedIn and Facebook.
| CureVac Contacts: | ||
| CureVac Media Contact Thorsten Sch ller Vice President Communications CureVac, T bingen, Germany T: +49 7071 9883-1577 thorsten.schueller@curevac.com | CureVac Investor Relations Contact Dr. Sarah Fakih Vice President Investor Relations CureVac, T bingen, Germany T: +49 7071 9883-1298 sarah.fakih@curevac.com | |
| Rentschler Biopharma Contact: | Media Inquiries: | |
| Rentschler Biopharma SE Dr. Cora Kaiser Senior Director Corporate Communication T: +49-7392-701-874 | MC Services AG Eva Bauer T: +49-89-210228-0 | U.S. Laurie Doyle T: +1-339-832-0752 |
| communications@rentschler-biopharma.com | rentschler@mc-services.eu |
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