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HomeACQUISITIONS and MERGERSBioNTech to Acquire GMP Manufacturing Site: To Expand COVID-19 Vaccine Production Capacity in First Half 2021

BioNTech to Acquire GMP Manufacturing Site: To Expand COVID-19 Vaccine Production Capacity in First Half 2021

September 17, 2020

BioNTech SE today announced the signing of a share purchase agreement with Novartis AG, Basel / Switzerland to acquire their GMP certified manufacturing facility in Marburg, Germany. The manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. A presentation about the announcement will be available here at 10 am CET.

BioNTech notes the transaction is expected to close in the fourth quarter of 2020. The Company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021, thanks to the established team and well-established drug substance and drug product manufacturing capabilities at the site.

The Marburg production site is a state-of-the-art, multi-platform GMP certified manufacturing facility that currently employs approximately 300 people. It is fully equipped for the production of recombinant proteins as well as cell and gene therapies, and holds cell culture labs and viral vector production capabilities, with further potential for long-term growth and expansion. Novartis has significantly invested in the site over the past five years, which is located in a life science industry park that is home to more than 10 companies with 6,000 employees in total, and also provides an excellent infrastructure for the Company. The industrial park is located within one hour from the Frankfurt airport and within 90 minutes from BioNTech’s headquarters in Mainz, Germany.

“This acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval. We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team and tapping into their impressive skills and expertise. From a strategic standpoint, the new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation,” said Dr. Sierk Poetting, Chief Financial Officer and Chief Operating Officer at BioNTech.

The acquisition will accelerate BioNTech’s efforts to scale-up its commercial manufacturing capacity to produce its mRNA COVID-19 vaccine candidate BNT162. The BNT162 program includes five mRNA vaccine candidates currently in clinical testing in the United States, Europe, South America, and China. BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in a global Phase 3 trial.

The facility is expected to operate as one of the largest mRNA manufacturing sites in Europe alongside two of BioNTech’s existing GMP facilities which currently produce the COVID-19 vaccine candidates for clinical trials and in addition to at least four Pfizer production sites in the United States and Europe. The Marburg facility is expected to start the production of mRNA and the LNP formulation for a COVID-19 vaccine in the first half of 2021, pending regulatory authorization or approval.

BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccine, antibody, and cell and gene therapy product candidates to support the development of its diversified cancer and infectious disease product pipeline. In addition, BioNTech intends to use the Marburg facility to contribute to the production of the COVID-19 vaccine for global supply, including to China, where it is partnered with Fosun Pharma, subject to regulatory authorization or approval.

The Marburg facility has a 100 years-long tradition of innovation: the manufacturing site, named Behringwerke, was established in 1904 by Emil von Behring, who developed the antitoxin for Diphtheria and Tetanus. He used the award money he received with the Nobel Prize in Medicine in 1901 to finance the manufacturing site. Since its founding in 1904, the Behringwerke has been at the forefront of pharmaceutical and biologic innovation, including the production of vaccines, resulting in a highly established infrastructure.

BioNTech and Novartis anticipate completing the transaction in the fourth quarter of 2020, subject to regulatory approval and the satisfaction of certain other customary closing conditions.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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