- 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 ( 
https://c212.net/c/link/?t=0&l=en&o=2771201-1&h=1127128411&u=https%3A%2F%2Fwww.bioreliance.com%2Fus%2Fservices%2Fbiomanufacturing-services%2Fgene-therapy-viral-vaccine-contract-manufacturing&a=BioReliance%C2%AE+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 ( 
https://c212.net/c/link/?t=0&l=en&o=2771201-1&h=3936349639&u=https%3A%2F%2Fwww.biotechforecasts.com%2FGT-19&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 ( 
https://c212.net/c/link/?t=0&l=en&o=2771201-1&h=2046504138&u=https%3A%2F%2Fwww.emdmillipore.com%2FUS%2Fen%2FMobius-Single-Use-Manufacturing%2FMobius-Single-Use-Bioreactors%2FN76b.qB.fW0AAAFZmkxiYtcY%2Cnav&a=Mobius%C2%AE+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 ( 
https://c212.net/c/link/?t=0&l=en&o=2771201-1&h=2811166643&u=https%3A%2F%2Fwww.merckgroup.com%2Fen%2Fcr-report%2F2018%2Fbusiness-ethics%2Fbioethics.html%23accordionSpecial1&a=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.

All Merck news releases are distributed by e-mail at the same time they become 
available on the Merck Website. Please go to www.merckgroup.com/subscribe to 
register online, change your selection or discontinue this service. 

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