- Introduces new synthetic cholesterol product nine months ahead of schedule

- Offers high purity, scalability, and consistent quality 

- One of a few companies that produces lipids in quantities needed to meet 
demand for mRNA therapeutics, including Pfizer-BioNTech Covid-19 Vaccine  

To meet the high demand for lipids, a key component of mRNA-based vaccines and 
therapeutics, Merck, a leading science and technology company, has launched a 
new, high-purity synthetic cholesterol product, nine months ahead of schedule.

Photo - 
https://mma.prnewswire.com/media/1517981/Optimized_Synthetic_Cholesterol.jpg  

"Tapping into two decades' experience of developing and manufacturing 
high-quality lipids, we designed a proprietary process to bring our new SAFC(R) 
synthetic cholesterol product to market nearly a year early," said Andrew 
Bulpin, head of Process Solutions, Life Science, at Merck. "With the 
introduction of our new SAFC(R) synthetic cholesterol product, we have 
increased our capacity by 50 times, helping biomanufacturers bring lifesaving 
therapies to patients faster." 

Merck manufactures lipids in Schaffhausen, Switzerland; Darmstadt, Germany; and 
St. Louis, Missouri, USA. While there are animal-derived and synthetic versions 
of cholesterol available on the market, Merck's synthetic cholesterol product 
offers high purity, scalability, and consistent quality.

This neutral lipid, used in commercially marketed products, is more than 99 
percent pure; offers high batch-to-batch consistency and is scalable under 
commercial GMP. Merck is one of a few companies in the world able to produce 
the quantities needed for lipid nanoparticle manufacturing and meet the quality 
requirements for mRNA therapeutics.

The launch of this new product follows the company's acquisition of AmpTec, a 
Hamburg, Germany, based mRNA contract development and manufacturing 
organization. By combining AmpTec's PCR-based mRNA technology with Merck's 
extensive expertise in lipids manufacturing, Merck can provide a truly 
integrated offering across the mRNA value chain. Merck has more than 20 years 
of experience developing and manufacturing high-quality lipids, following GMP 
processes. The company provides regulatory support through all phases of 
clinical development and commercialization, as well as deep analytical 
expertise.

Merck is collaborating with more than 50 companies to support their efforts in 
the development and production of Covid-19 vaccines and treatments, providing 
custom lipids, as well as other critical raw materials, processing equipment 
and services used in mRNA drugs and vaccines manufacturing. In early February 
2021, the company announced the extension of its strategic partnership with 
BioNTech to significantly accelerate the supply of urgently needed lipids and 
increase the quantities to be delivered toward the end of 2021. The lipids will 
be used for the production of the Pfizer-BioNTech Covid-19 vaccine.

The company recently announced the addition of a single-use assembly production 
unit at its Life Science Center in Molsheim, France. The company also recently 
announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, 
Switzerland; Carlsbad, California; Madison, Wisconsin; Jaffrey, New Hampshire; 
and Danvers, Massachusetts. At the latter site, Merck is working to double the 
local single-use production capacity by the end of 2021. These expansions are 
part of an ambitious, multi-year program to increase the industrial capacity 
and Merck's capabilities to support growing global demand for lifesaving 
medications and to make significant contributions to public health.

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About Merck
Merck, a leading science and technology company, operates across healthcare, 
life science and electronics. Around 58,000 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 2020, Merck generated 
sales of EUR 17.5 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 Electronics.

SOURCE  Merck

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