BioNTech provides Update on Vaccine Production Status at Marburg Manufacturing Site
March 26 2021 - 9:45AM
MAINZ, GERMANY, March 26, 2021 (GLOBE
NEWSWIRE) — BioNTech SE today announced that the European
Medicines Agency (EMA) approved the manufacturing of the COVID-19
vaccine drug product at the facility in Marburg. As part of the
process, EMA has approved the production of the drug
substance, the mRNA, at the Marburg site over the course of this
week. The approvals make BioNTech’s Marburg manufacturing site one
of the largest mRNA vaccine manufacturing sites in Europe as well
as worldwide with an annual production capacity of up to one
billion doses of our COVID-19 vaccine, once fully operational. Due
to optimized operational efficiencies which were initiated last
year, BioNTech has been able to increase the expected annual
manufacturing capacity by 250 million doses.
A single mRNA batch of the current scale is
sufficient to produce around eight million vaccine doses.
Currently, 400 BioNTech employees work in Marburg, 200 of them in
24/7 shifts in order to maximize the production’s output. Based on
the approval by the EMA, first drug product batches of the vaccine
can now be delivered to partner sites for sterile fill and finish,
before distribution to the European Union and countries worldwide.
The first batches of vaccines manufactured at the Marburg site are
expected to be delivered in the second half of April.
In total, 50,000 steps are required from
manufacturing the mRNA to the bulk drug substance which then can be
handed over for fill and finish. Materials and components for
production arrive from a global supply chain that has been
dramatically expanded in the last 12 months.
BioNTech’s manufacturing facility in Marburg is
a GMP-certified manufacturing facility. Good manufacturing practice
(GMP) is a system of regulatory standards for ensuring that
products are consistently produced and controlled according to
quality standards aiming for a high level of drug quality and
patient safety. The GMP regulations have been developed over
decades to minimize the risks involved in any pharmaceutical
production, including the vaccine production that cannot be
eliminated through testing the final product. The production of
vaccines under GMP standards are a prerequisite for the validation
of the manufacturing processes by the EMA.
Together with our partner Pfizer, we are working
continuously on multiple initiatives to respond to global demand. A
key factor in the expansion of our manufacturing network has been
the set-up of this new manufacturing site in Marburg, Germany.
BioNTech plans to be able to produce up to 250 million doses of
BNT162b2 in the first half of 2021. The first vaccines manufactured
at the Marburg site are scheduled for distribution in early
April.
The vaccine, which is based on BioNTech’s
proprietary mRNA technology, was developed by both BioNTech and
Pfizer. BioNTech is the Marketing Authorization Holder in the
European Union, and the holder of emergency use authorizations or
equivalent in the United States, United Kingdom, Canada and other
countries in advance of a planned application for full marketing
authorizations in these countries.
About BioNTechBiopharmaceutical New
Technologies is a next generation immunotherapy company pioneering
novel therapies for cancer and other serious diseases. The Company
exploits a wide array of computational discovery and therapeutic
drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells,
bi-specific checkpoint immuno-modulators, targeted cancer
antibodies and small molecules. Based on its deep expertise in mRNA
vaccine development and in-house manufacturing capabilities,
BioNTech and its collaborators are developing multiple mRNA vaccine
candidates for a range of infectious diseases alongside its diverse
oncology pipeline. BioNTech has established a broad set of
relationships with multiple global pharmaceutical collaborators,
including Genmab, Sanofi, Bayer Animal Health, Genentech, a member
of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit www.BioNTech.de.
BioNTech Forward-looking StatementsThis
statement contains “forward-looking statements” of BioNTech within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements may include, but may not be
limited to, statements concerning: BioNTech’s efforts to combat
COVID-19; the collaboration between BioNTech and Pfizer regarding a
COVID-19 vaccine; our contemplated shipping and storage plan,
including our estimated product shelf life at various temperatures;
and the ability of BioNTech to supply the quantities of BNT162 to
support clinical development and market demand, including our
production estimate for 2021 as well as the timing and expectations
of manufacturing capacities of the manufacturing network. Any
forward-looking statements in this statement are based on
BioNTech’s current expectations and beliefs of future events, and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to: competition to
create a vaccine for COVID-19; the ability to effectively scale our
productions capabilities; and other potential difficulties.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report for the Three and
Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its
Current Report on Form 6-K filed with the SEC on November 10, which
is available on the SEC’s website at www.sec.gov. All information
in this statement is as of the date of the release, and BioNTech
undertakes no duty to update this information unless required by
law.
BioNTech Contacts:
Media RelationsJasmina Alatovic+49 6131
9084-0Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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