Gene therapy “Made in Europe”: Novartis is expanding Kundl to become a competence center for nucleic acid production

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Opening of a high-tech production facility for plasmids – the most important raw material for cell and gene therapies with the prospect of significant expansion

Vienna / Kundl (OTS)

  • The rapidly growing global demand for plasmids for internal development programs and for the Novartis Gene Therapies product that is already on the market is to be largely covered from Kundl from 2021
  • A total of USD 20.4 million (equivalent to EUR 17.2 million) is to be invested in nucleic acid production lines at the site by mid-2021, and around 45 highly qualified employees are to be employed for this purpose

Novartis is increasingly relying on Europe for the production of its innovative gene therapies: In order to expand the production of nucleic acids for its commercial therapies as well as for the various development projects, Novartis is expanding the Kundl location into a competence center. Today a new facility was inaugurated, with which plasmids for the study medication of gene therapy pipeline programs are now being produced in Austria. Plasmids are circular DNA molecules that are required for cell and gene therapies. They are therefore a crucial component of all innovative cell and gene therapies from Novartis. Such as the gene therapy platform from Novartis Gene Therapies, with which the company ushers in a new era in the treatment of monogenic neuromuscular hereditary diseases.

“The need for nucleic acid products has risen sharply as a result of increasing research in the field of cell and gene therapies. Establishing our own production facilities in this high-tech area is an important strategic step in aligning our production network with the future requirements of medicine, ”explained Steffen Lang, Global Head of Novartis Technical Operations and member of the Novartis Executive Board. “The new facility in Kundl is an ideal addition to our global production network for cell and gene therapies. We intend to further expand the capacities for the production of nucleic acid products at the site. “

And Mario Riesner, Managing Director of Sandoz GmbH, added: “We are delighted that we can support patients all over the world who suffer from serious monogenic hereditary diseases with our work. With these new systems we are making a significant contribution to the supply of innovative gene therapeutics and are opening a new chapter at our traditional location in Kundl. We have been pioneers here since 1946 – from the beginnings with antibiotics to the first biosimilar and now a central production facility for nucleic acids. “

Investment in technological advancement

Novartis Gene Therapies is the world’s leading gene therapy company and is redefining the possibilities for patients affected by life-threatening genetic diseases and their families with its innovative gene therapy platform. At the Kundl site, Novartis has already invested USD 15.7 million in the new facility for the production of plasmid DNA this year. Another mRNA production facility will be built by the middle of next year with a further USD 4.7 million. A total of 45 people will then be employed in nucleic acid production. At the competence center, employees are trained for the highly specialized functions in the manufacture of nucleic acids. The center also has its own development department, which is specifically dedicated to the technological advancement of gene therapies.

Plasmids: Instructions for cells to treat rare genetic defects

Gene therapies are manufactured in a long and complex process that involves a number of biological steps. An important part of these innovative therapies is also the smallest: plasmids. These circular DNA molecules contain the instructions to enable cells in the patient’s body to manufacture Novartis gene therapies. The production of the plasmid DNA takes about seven days. Three to four of these plasmids are required for the various cell and gene therapies from Novartis. The DNA molecules produced in Kundl are brought together in a bioreactor with special cell lines in order to produce the adeno-associated viruses (AAVs). Once the virus envelopes have taken up DNA plasmids, they are called AAV vectors. These serve as a vehicle to transport the therapeutically effective genetic material into the cells of the patient. It takes a total of 30 days, for example, until the single-use gene therapy against spinal muscular atrophy is produced for the patient, individually tailored to their weight.

About Novartis

Novartis is rethinking medicine to help people live better and longer lives. As a leading global pharmaceutical company, we leverage scientific innovation and digital technology to develop breakthrough therapies in areas of great unmet medical need. We are regularly among those companies that invest the most in research and development worldwide. Novartis products reach nearly 800 million people worldwide, and we are looking for new ways to expand access to our latest therapies. Around 109,000 people from over 145 nations are employed by Novartis worldwide. Further information is available on the Internet at ww.novartis.com.

About Novartis Austria

We are rethinking medicine – on the pulse of society, in the heart of Austria. The Austrian Novartis Group is one of the country’s leading pharmaceutical companies and is divided into the business areas of innovative drugs (Pharmaceuticals, Oncology) and generics (Sandoz). Our employees live our mission every day: to improve and extend people’s lives. We reach 5 million domestic patients with our pharmaceuticals. The Tyrolean Novartis locations in Kundl / Schaftenau are part of the company’s global network of research and development centers. Further information can be found at www.novartis.at

Inquiries & contact:

Novartis Pharma GmbH
Simone Farina, Bakk. Comm.
Head Pharma Communications
01 86657-6013
simone.farina@novartis.com
www.novartis.at



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