PR89724

DARMSTADT, Germany, May 26, 2021 /PRNewswire=KYODO JBN/ --

- 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.

All Merck news releases are distributed by email 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 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

CONTACT: Media Relations, gangolf.schrimpf@merckgroup.com, Phone: +49 6151

72-9591; Investor Relations, investor.relations@merckgroup.com, Phone: +49 6151

72-3321