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CureVac AG. (6/26/17). "Press Release: CureVac Expands GMP Production Capacities for RNA Products". Tübingen.

Region Region Tübingen
  Country Germany
Organisations Organisation CureVac AG
  Group CureVac (Group)
  Organisation 2 Bill and Melinda Gates Foundation
Products Product RNA-based therapeutic
  Product 2 RNActive® vaccination technology
Person Person Lauterbach, Verena (CureVac GmbH 201603 Senior Director Communications)
     


Supply for Full RNA Clinical Pipeline and Later Commercialization Secured


CureVac AG, a fully-integrated biopharmaceutical company pioneering the field of mRNA-based drugs, announced during a public open door event at its main location in Tübingen, Germany, on June 24 the extension of its GMP production capabilities to meet the clinical and future commercial needs of its mRNA product pipeline as the company advances towards its goal of bringing the first mRNA product to the market.

Since 2006, CureVac has operated the first GMP-compliant production plant worldwide with two multi-product suites – GMP I and GMP II – for large RNA molecules for medical applications against cancer, infectious diseases and other illnesses. Since 2008, these suites have supplied mRNA for CureVac’s multiple clinical studies.

The RNA company is advancing by taking its GMP production capabilities to the next level. CureVac is currently completing the development of its third in-house suite, GMP III. This suite will operate under a newly developed and patent-protected process optimized for large scale production. Manufacturing of RNA products in this facility will begin in 2018.

Expanding its manufacturing capabilities is CureVac’s construction of a new building, which is designed for the development of a GMP production process on an industrial scale. Construction has now started; the new facility, GMP IV, is expected to be fully commissioned in 2019 and is designed with a modular concept that gives CureVac the ability to rapidly adapt to product development needs. GMP IV’s production process design will cover a wide variety of different RNA-based products and is planned to begin with a target capacity of approximately 30 million doses per year. CureVac also has the ability to extend the building to fulfill future market needs for its RNA products onsite in Tübingen.

Florian von der Mülbe, Ph.D., co-founder and Chief Operating Officer of CureVac, stated, “At CureVac, we believe it is mission-critical to produce high quality RNA products for all development stages, from research to clinical grade, and to drive product development forward. With the construction of GMP IV, we are in a great position to be the first RNA company with commercial-scale production know-how and capabilities. Thereby we reach a major milestone in our collaboration with the Bill & Melinda Gates Foundation. Our ex-pertise in RNA production makes us ideally positioned to also extend relationships with both existing partners and future collaborators.”

Since its foundation in 2000, mRNA pioneer CureVac continuously increases its expertise and know-how in formulating, optimizing and manufacturing the versatile molecule, mRNA. Using mRNA for medical treatment became one of biotech’s hotspots within the last years.

Further information on CureVac’s mRNA production can be found here.


About CureVac AG

Founded in 2000 as a spin-off from the University of Tübingen in Germany, CureVac is a leading company in the field of mRNA technology and was the first company to start clin-ical trials on mRNA-based drugs. The biopharmaceutical company has more than 17 years of expertise in handling and optimizing this versatile molecule for medical purposes.

The basic principle of CureVac's proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. The company applies its technologies for the development of cancer therapies, prophylactic vaccines and molecular therapies.

Since its inception, strongly backed by SAP founder Dietmar Hopp’s dievini, CureVac has received approximately $370 million (€355 million) in equity investments including an investment of the Bill & Melinda Gates Foundation of $ 52million in 2015. CureVac has entered into various collaborations with multinational corporations and organizations, including agreements with Boehringer Ingelheim, Sanofi Pasteur, the Bill & Melinda Gates Foundation and IAVI.

In 2006, CureVac successfully established the worldwide first GMP facility for the manu-facturing of mRNA. In 2016 CureVac started the establishment and construction of industrial scale production facilities.

For more information, please visit www.curevac.com


***


Media Contacts

Verena Lauterbach, Senior Manager Communications
CureVac AG, Tübingen, Germany
T: +49 (0) 7071 9883 1756
verena.lauterbach@curevac.com

Andrew Mielach, Vice President
Tiberend Strategic Advisors, New York
T: +1 212 375 2694
amielach@tiberend.com

   
Record changed: 2017-07-05

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