Merck Boosts Commercial Viral Vector and Gene Therapy Manufacturing Capacity
PR83603
DARMSTADT, Germany, Apr. 21, 2020 /PRNewswire=KYODO JBN/---
- New, EUROS 100 million facility will more than double existing production
capacity
- Supports large-scale commercial manufacturing of viral and gene therapy
products
Merck, a leading science and technology company, today announced a second
Carlsbad, California, U.S.A.-based facility for its BioReliance(R) viral and
gene therapy service offering (
). The new, EUROS 100 million commercial facility is expected to open next
year.
Photo - https://mma.prnewswire.com/media/1156781/Merck_Gene_Therapy.jpg
"Viral vector manufacturing has transitioned from a niche industry to the
cornerstone of the future of biopharmaceuticals," said Udit Batra, member of
the Merck Executive Board and CEO, Life Science. "Few companies have the scale
and quality systems in place for manufacturing commercial viral vector
products. Building on our success in helping customers commercialize their gene
therapies made possible by viral vectors, our expansion will help innovators
produce at a scale that ensures these therapies reach more patients in need."
Merck's Life Science business sector facility in Carlsbad manufactures gene
therapies for its customers globally. Gene therapy involves the delivery of a
genetic payload into patient cells to produce a therapeutic effect such as
correction of a mutated gene or retargeting of an immune cell to fight cancer.
Diseases such as hemophilia and cancer are being investigated using this
technique where a single dose may cure the disease. Viral vectors are often
called the most complex therapeutic manufactured today. The gene therapy
market, which accounted for $1 billion in 2018, is expected to reach $10
billion by 2026, according to a recent Biotech Forecasts global market analysis
and industry forecast (
).
Merck's new, 140,000-square-foot manufacturing facility will support viral and
gene therapy production at the 1000-liter scale using its Mobius(R) single-use
equipment (
). The site is part of the Life Science business' expanding product and service
offering to the viral and gene therapy marketplace. Merck has close to three
decades of experience in cell and gene therapy, and its Carlsbad, California,
U.S.A site has been involved in the gene therapy area since 1997, near the time
that clinical trials for gene therapy began. In the interim, the company
manufactured viral vectors for two cell and gene therapy products.
This expansion underscores Merck's continued investment in viral and gene
therapies from clinical to commercial scale and marks the second major
investment at its Carlsbad facility in recent years. In 2016, the investments
resulted in nearly doubling its former production capacity. The upgraded
facility grew from 44,000 square feet to 65,000 square feet. Today, the
Carlsbad site is home to 16 modular viral bulk manufacturing cleanroom suites
with single-use equipment and two fill/finish suites for gene therapy, viral
vaccine and immunotherapy products. With the expansion, the company will add 11
suites, bringing the total to 27, used in various steps of manufacturing.
In addition to contract development and manufacturing services for viral
vectors, Merck also provides seamless manufacturing and testing services at its
pharma and biopharma testing sites globally.
Merck recognizes that cell and gene therapy has resulted in major advancements
in medicine. The company supports these therapies under consideration of
ethical and legal standards; it has established an independent, external
Bioethics Advisory Panel (
). This panel provides guidance on various topics, including gene editing and
stem cells usage, in which its businesses are involved. The company has also
defined a clear operational position taking into account scientific and
societal issues.
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About Merck
Merck, a leading science and technology company, operates across healthcare,
life science and performance materials. Around 57,000 employees work to make a
positive difference to millions of people's lives every day by creating more
joyful and sustainable ways to live. From advancing gene editing technologies
and discovering unique ways to treat the most challenging diseases to enabling
the intelligence of devices – the company is everywhere. In 2019, Merck
generated sales of EUROS 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to
Merck's technological and scientific advances. This is how Merck has thrived
since its founding in 1668. The founding family remains the majority owner of
the publicly listed company. Merck holds the global rights to the Merck name
and brand. The only exceptions are the United States and Canada, where the
business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma
in life science and EMD Performance Materials.
SOURCE: Merck
CONTACT: Andreas.cezanne@merckgroup.com
Phone: +49 6151 72-44461
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