Can you provide more details on Merck's recent announcement about becoming the first CTDMO to offer integrated services for mRNA development? What are the key components of their integrated services?

With the opening of its new GMP-grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany, Merck can now provide its clients mRNA drug substance services at all scales and applications from pre-clinical to commercial, including mRNA process and analytical development, to mRNA synthesis, purification and release of the final mRNA drug substance. This includes capabilities set up to tech transfer in clients manufacturing processes, or capacity to leverage our proprietary PCR-based, scalable, GMP mRNA production platform. With these new facilities, we are now the single source provider of mRNA drug substance for all stages of a mRNA program’s life cycle. These facility openings complement our mRNA value chain with facilities for custom and off the shelf lipids as well as LNP formulation and drug product manufacturing capabilities in Europe and the USA.

The expansion of Merck's GMP-grade mRNA drug substance manufacturing sites in Germany is part of their €1 billion investment plan. Could you elaborate on the significance of this investment and how it contributes to the advancement of mRNA technologies?

The site openings in Hamburg and Darmstadt, Germany represent € 28 million of the company’s continued € 1 billion investment to advance mRNA technologies. These investments are part of Merck’s overall strategy to build its global mRNA network and capabilities through investments, as well as key acquisitions such as AmpTec and Exelead. 

Since the 1990s, Merck has worked with researchers to ensure they have the critical components and raw materials needed to explore mRNA’s potential, so we have the experience and expertise to move this technology forward into today’s age and beyond. We recently sponsored a survey with vaccine manufacturers in the Asia-Pacific region. Respondents called mRNA technology a “game-changer.” With 87% of respondents deeming mRNA a key modality for the future, over half said they planned on revamping or building new mRNA manufacturing facilities to meet predicted demand. This year’s Physiology or Medicine Nobel Prize winners are Katalin Karikó and Drew Weissman for their discoveries around mRNA vaccines for COVID-19, which only reinforces the revolutionary nature of this technology. We are truly following the science and meeting the needs of our clients, while propelling the promise of mRNA.

How does Merck's integrated offering, covering all stages of mRNA development, manufacturing, and commercialization, impact the biotechnology and pharmaceutical industries? What benefits does it offer to clients?

mRNA’s superpower is its unprecedented flexibility - promising what no other modality can. It can be used as for much more than vaccines for infectious diseases or as cancer therapeutic. Rather than only treating  diseases such as cancer, mRNA can also be used to fix or replace missing genes and thus potentially cure, by targeting the source of the disease, using the patient’s own body to produce proteins to fight disease – a unique advantage over conventional biologics or small molecules.  mRNA promises to speed development and bring therapies to patients faster, compared to other traditional modalities, by simply changing the sequence encoded within the mRNA.

The overall mRNA development and manufacturing involves a complex and rigorous process that can encounter various challenges from mRNA sequence design, to finding the right formulation, securing supply of critical raw materials such as lipids, and finding experienced partners with the capacity to support a program throughout all stages. Additional challenges include ensuring safety and efficacy, scaling up production, cost of development, and regulatory hurdles, all of which are benefits to working with a fully integrated service offering.

Can you explain the role of Merck's acquisitions, such as AmpTec and Exelead, in bolstering their capabilities in the mRNA field? How do these acquisitions fit into their broader strategy?

mRNA is one of the novel modalities that Merck's Life Science business sector has made significant investments to advance over past few years, accomplishing this through the 2021 and 2022 acquisitions of Amptec and Exelead, respectively, to enable end-to-end services across the mRNA value chain through growth in ongoing investments in our capacity and capabilities, and through the introduction of new product platforms and technologies, all to ensure we are providing our clients with the right solutions to overcome challenges in their mRNA needs.

While Covid made mRNA a household name, mRNA has been explored for more than 60 years. Merck began producing lipids in 1995 and we have been investing in it ever since, through partnerships such as our work with BioNTech to significantly accelerate the supply of urgently needed lipids, as well as through acquisitions such as AmpTec and Exelead, which enabled us to become one of the leading Contract Development and Manufacturing (CDMO) players in mRNA vaccines and therapeutics. We now provide an integrated offering across the mRNA value chain, from pre-clinical to commercial.

Merck has emphasized the importance of mRNA technology in potentially curing diseases like cancer and heart disease. Could you provide examples or insights into specific projects or collaborations where Merck's mRNA expertise has made a significant impact in the field of medical research?

In 2021 we announced an extension of our strategic partnership with BioNTech to accelerate the supply of urgently needed lipids and increase the amount of lipid delivery for use in the Pfizer-BioNTech COVID-19 vaccine. With the severely increased need for these lipids, this required the development of production technologies and the implementation of new, highly complex process steps. Merck was only one of a few companies in the world that was equipped to produce these custom lipids according to the highest quality requirements needed for vaccine production. Our mRNA services played a significant role in combating this global health crisis.

Merck's Millipore® CTDMO Services seem to cover a wide range of pharmaceutical products beyond mRNA, including monoclonal antibodies, viral vectors, and small molecules. How do these services contribute to Merck's overall growth strategy, and what role do they play in achieving the company's sales goals for 2025?

As an organization, we are well positioned with respect to growth trends and have a robust strategy to actively pursue them as a diversified industry leader. We have a clear focus on strengthening the core (as an established player in many attractive segments such as bioprocessing, chemistry consumables, and lab water) and expanding in high-growth segments. Our CTDMO services play a big role here, as well as emerging regions – Asia-Pacific, and digitally enabled solutions. Our strategic priorities are complemented by an increased focus on innovation, digital, and strategic capital allocation. At Merck, we take the long-term view and see key drivers, such as the rise of next-gen manufacturing processes, novel modalities, regionalization, and digitalization/automation, as critical to securing our growth for the next decade and beyond. This is reflected in the significant investments we are making in each of these areas.

We are focused on shaping the evolution of the life science ecosystem and providing leading innovative solutions to continue to impact life and health with science.

arcilla.fran@biopharmaapac.com