Swissmedic Grants Good Manufacturing Practice Multi-Product License to Biogen Biologics Facility in Solothurn, Switzerland
May 20 2021 - 4:06PM
Swissmedic Grants Good Manufacturing Practice Multi-Product License
to Biogen Biologics Facility in Solothurn, Switzerland
Biogen Inc. (Nasdaq: BIIB) today announced that its next
generation manufacturing facility in Solothurn, Switzerland has
received a Good Manufacturing Practice (GMP) multi-product license
from the Swiss Agency for Therapeutic Products (SWISSMEDIC).
The Solothurn facility combines Biogen’s latest concepts for
fed-batch cell culture technology and protein purification,
enabling the large-scale production of biopharmaceuticals. With
more than 500 employees, the highly modernized facility design
consists of multiple bio-manufacturing cells (BMCs) with site
infrastructure in place to support future BMCs if needed. The GMP
licensure is an important step in the readiness of the site, which
enables the future submissions of product files to regulatory
authorities. Notably, the site could support the manufacturing of
aducanumab if approved, expanding on Biogen’s existing capacity in
Research Triangle Park, North Carolina, as well as the potential
manufacturing of lecanemab (BAN2401) and other biologic assets.
“GMP licensure is a foundational and critical step forward
towards our Solothurn manufacturing site creating, safeguarding and
supplying high quality medicine to patients,” said Nicole Murphy,
Head of Global Manufacturing and Technical Operations at Biogen.
“We are excited about the potential of our state-of-the-art
manufacturing site in Switzerland where innovation is driven by our
highly talented workforce.”As part of Biogen’s sustainability
goals, the Solothurn facility has implemented design features to
keep emissions to the lowest level possible with the goal to become
fossil fuel free by 2040. The building design and equipment will
help to generate 83% fewer carbon emissions, will lower energy
consumption by 79% and will reduce water usage per kilogram of
output by 89%.
About BiogenAt Biogen, our mission is clear: we
are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
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Biogen Safe HarborThis news release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, relating to our Solothurn manufacturing
facility; the anticipated benefits and potential of our Solothurn
manufacturing facility; potential regulatory discussions,
submissions and approvals and the timing thereof; the potential of
our commercial business and pipeline programs, including aducanumab
and lecanemab; risks and uncertainties associated with drug
development and commercialization; our strategy and plans; results
that may be achieved through our environmental, sustainability and
corporate responsibility initiatives; and the anticipated timeline
of our environmental, sustainability and corporate responsibility
initiatives. These forward-looking statements may be identified by
words such as “aim,” “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,”
“potential,” “will,” “would” and other words and terms of similar
meaning. You should not place undue reliance on these
statements.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including, without limitation, uncertainty as to
whether the anticipated benefits of our Solothurn manufacturing
facility can be achieved; risks of unexpected hurdles, costs or
delays; failure to obtain regulatory approvals; risks relating to
investment in our manufacturing capacity; problems with our
manufacturing processes; actual timing and content of submissions
to and decisions made by the regulatory authorities; regulatory
submissions may take longer or be more difficult to complete than
expected; regulatory authorities may require additional information
or further studies, or may fail or refuse to approve or may delay
approval of our drug candidates, including aducanumab; risks that
the goals of our environmental, sustainability and corporate
responsibility initiatives will be completed in a timely manner or
at all; and the direct and indirect impacts of the ongoing COVID-19
pandemic on our business, results of operations and financial
condition. The foregoing sets forth many, but not all, of the
factors that could cause actual results to differ from our
expectations in any forward-looking statement. Investors should
consider this cautionary statement as well as the risk factors
identified in our most recent annual or quarterly report and in
other reports we have filed with the U.S. Securities and Exchange
Commission. These statements are based on our current beliefs and
expectations and speak only as of the date of this news release. We
do not undertake any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.
MEDIA
CONTACT: |
INVESTOR
CONTACT: |
David Caouette |
Mike Hencke |
+1 617 679-4945 |
+1 781 464-2442 |
Public.affairs@biogen.com |
IR@biogen.com |
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