In a significant milestone for the pharmaceutical industry, Merck KGaA has established itself as the pioneer Contract Testing, Development, and Manufacturing Organization (CTDMO) to provide integrated services covering every crucial facet of mRNA development, production, and commercialization, including essential products and testing. This groundbreaking move is accompanied by the inauguration of two state-of-the-art GMP-grade mRNA drug substance manufacturing facilities in Darmstadt and Hamburg, Germany.
Empowering mRNA Advancements
Merck KGaA, Darmstadt, Germany, a prominent name in science and technology, has taken a leap forward by becoming the inaugural CTDMO to offer comprehensive services spanning the entire spectrum of mRNA R&D, production, and distribution. This pioneering move is underpinned by the unveiling of two cutting-edge Good Manufacturing Practice (GMP) compliant facilities for manufacturing mRNA drug substances, strategically located in Darmstadt and Hamburg, Germany.
A €28 Million Fuels Merck KGaA’s mRNA Advancements
Merck’s dedication to advancing mRNA technologies is evident through its ongoing €1 billion investment, aimed at fortifying its global mRNA network and capabilities. This commitment extends to strategic acquisitions, such as AmpTec and Exelead, further underscoring the company’s resolute commitment to shaping the future of mRNA-based therapies. The investment, amounting to €28 million in the establishment of these GMP mRNA drug substance manufacturing sites, also translates into the creation of 75 new job opportunities. These sites will enable Merck to cater to clients with mRNA services across all scales and applications, spanning from pre-clinical research to commercialization.
A Holistic Approach to mRNA Services
One of the defining features of Merck’s integrated mRNA services is its focus on eliminating complexities and enhancing speed-to-market for clients. This streamlined and harmonized approach encompasses all aspects of mRNA development, manufacturing, and testing, thereby simplifying the entire process for those harnessing the transformative potential of mRNA technology.
Dirk Lange, Head of Life Science Services within Merck’s Life Science business sector noted:
“mRNA has emerged as the breakthrough technology of this century, providing great promise to not only treat but potentially cure a wide array of diseases such as cancer, heart disease, and muscular dystrophy. We are now the first CTDMO to streamline the entire mRNA process for our clients.”
A Legacy of mRNA Expertise
Merck’s legacy in supporting mRNA research dates back to the 1990s when it initiated collaborations with researchers to ensure the availability of critical components and raw materials essential for exploring mRNA’s potential. Over the years, Merck has uniquely combined its mRNA expertise, cutting-edge technologies, regulatory acumen, and product portfolio to expedite mRNA manufacturing and testing. The company’s comprehensive suite of mRNA services spans its global network of facilities in Schaffhausen, Switzerland; Indianapolis, Indiana, USA; Darmstadt, and Hamburg, Germany.
Pioneering Partnerships for Progress
Dr. Simone Spuler, head of the Myology Lab at the Experimental and Clinical Research Center (ECRC), a joint institution of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité – Universitätsmedizin Berlin, shared insights on the impact of Merck’s collaborative approach. Dr. Spuler noted:
“As a researcher working on finding cures with mRNA technology and as a believer in its curative promise, collaborating with Merck has helped to advance my research in finding a cure by leveraging mRNA’s promise for muscular dystrophy.”
A Comprehensive Portfolio
In addition to its pioneering mRNA services, Merck’s Millipore® CTDMO Services offer a comprehensive range of capabilities, spanning from pre-clinical to commercial, for monoclonal antibodies and recombinant proteins (mAb and r-proteins), viral vectors (VV), small molecules, and high-potency active pharmaceutical ingredients (HPAPI), as well as antibody-drug conjugates (ADCs). These services are complemented by integrated analytical development, biosafety testing, and product characterization, positioning Merck as a pivotal player in the pharmaceutical landscape.
Driving Growth through Innovation
Merck’s Millipore® CTDMO Services are an integral part of its Life Science Services business unit, which, alongside the Process Solutions business, constitutes one of Merck’s “Big 3” growth drivers. The company has set ambitious targets, aiming to achieve Group sales of approximately €25 billion by 2025, with around 80% of this growth anticipated to emanate from the “Big 3” businesses.
In unveiling these integrated mRNA services and state-of-the-art manufacturing facilities, Merck KGaA reinforces its position as a frontrunner in advancing the field of mRNA technologies, setting the stage for groundbreaking developments in the pharmaceutical industry.
For more information, please visit: www.merckgroup.com
Original Source: Merck KGaA, Darmstadt, Germany Press Release