MilliporeSigma Invests $76 Million to Expand ADC Manufacturing for Novel Cancer Therapies

News Release

• Triples manufacturing capacity to meet increased global demand for antibody-drug conjugates (ADCs)
• Reinforces position as first commercially approved contract development and manufacturing organization (CDMO) for ADCs in North America
• Expansion to create 170 jobs at Bioconjugation Center of Excellence in St. Louis, Missouri

St. Louis, Missouri, October 29, 2024 – MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, today announced a $76 million expansion of its ADC manufacturing capabilities and capacity at its Bioconjugation Center of Excellence facility in St. Louis, Missouri. This investment will triple existing capacity and enhance the company’s contract development and manufacturing organization (CDMO) offering, reinforcing its commitment to clients and patients.

The investment represents a critical step in the company’s ongoing growth journey to partner with new and existing clients as they advance their drug development pipelines. With additional capacity and by scaling utilities and enhancing Process and Analytical Development (PAD) labs, MilliporeSigma will provide industry-leading support for early-stage and commercial bioconjugates. The company’s goal is to ensure clients can bring their innovations to market more effectively and with shorter turnaround times.

“We are shaping tomorrow’s cancer care, today. With this investment, we are not just enhancing our capabilities; we are investing in our clients’ success by accelerating innovation and development to ultimately deliver novel therapies to patients more quickly,” said Benjamin Hein, Head of Life Science Services, Life Science business of Merck KGaA, Darmstadt, Germany. “ADCs represent a transformative approach to oncology, enabling targeted therapies that minimize damage to healthy tissues. As the market for this novel modality grows and the medical community adopts them as first-line treatments, it may mean that fewer patients need invasive treatments like chemotherapy and radiation that cause significant side effects.”

The ADC capacity expansion project will:

• Upgrade 34,000 square feet to benefit the Process and Analytical Development, Quality Control, Research and Development, Manufacturing, and Logistics departments.
• Add new labs, a dedicated manufacturing buffer preparation facility, and a cold storage and a GMP-controlled room temperature (CRT) warehouse that will be located close to the existing facility.

Building on its reputation as the first commercially approved ADC CDMO in North America, the Life Science business of Merck KGaA, Darmstadt, Germany, has made significant investments to expand its ADC manufacturing capabilities for clients worldwide. In 2022, the company opened its $65 million, 70,000-square foot facility in Verona, Wisconsin, USA, dedicated to doubling the production of the most highly potent active pharmaceutical ingredients (HPAPIs) used in novel cancer therapies, including ADCs.

In addition to recent footprint and capacity expansions, the company continues to innovate differentiated technologies and platforms that accelerate the future potential of this novel modality.

In September 2024, the company launched the Mobius ^® ADC Reactor, the first scalable single-use mixer specifically designed for ADC manufacturing. MilliporeSigma also launched ChetoSensar^®, a technology that alleviates ADC solubility challenges, as well as the ADCore portfolio of advanced payload intermediates, which significantly reduce development and manufacturing time by enabling more efficient synthetic pathways for some of the most common payloads used in ADCs, increasing speed-to-market by up to a year.

With more than 35 years of CDMO experience in the development and manufacturing of ADCs, HPAPIs, linker/payloads, and mAbs, MilliporeSigma has evolved alongside the bioconjugate market, offering significant expertise in both clinical and commercial manufacturing:

• Clinical services: Supported more than 60 Investigational New Drugs (INDs), representing ~20% of all ADCs entering clinical trials.
• Commercial services: Supported approximately 50% of commercially approved ADCs with bioconjugation or linker/payload services.
• Integrated services: Leveraged its extensive CDMO experience in viral vector, lipids, LNP, and mRNA manufacturing — from pre-clinical to commercial — helping to accelerate drug development timelines and production with a single, highly experienced partner.

Cancer is the second leading cause of death worldwide¹ . ADCs are one of the most promising drug modalities for cancer treatment. Since 2017, there has been a significant increase in approvals for ADCs. This growth is attributed to advancements in linker and conjugation technologies that improve safety and efficacy, as well as the designation of ADCs as first-line therapies. As a result, confidence in this modality has risen, leading to an annual increase of over 30% in the number of molecules in the global ADC pipeline. As the pipeline matures with continuous and accelerated approvals, the ADC therapeutics market is expected to grow at 15% CAGR by 2028², substantiating this modality’s promise as a targeted novel therapy.

The ability of ADCs to reach and target diseased cells without damaging nearby healthy tissues is also demonstrating significant potential beyond oncology, particularly with innovative bioconjugates like Antibody-Oligonucleotide Conjugates (AOCs) and Radioimmunoconjugates. These bioconjugates are being explored for a variety of applications, including autoimmune diseases, infectious diseases, and neurodegenerative disorders. This expanding scope highlights the transformative role of bioconjugates in advancing personalized medicine across diverse therapeutic areas.

¹ “Global Cancer Facts & Figures 4th Edition, https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf

² “Antibody Drug Conjugates (ADC) Market - Global Forecast to 2028,” https://www.marketsandmarkets.com/Market-Reports/antibody-drug-conjugates-market-122857391.html