Merck Advances Next-Generation Antibody-Drug Conjugate (ADC) Therapies with Innovative Platforms and Expanded Manufacturing Capacity

- Merck's uniqueChetoSensar™Technologytechnology, by mitigating solubility challenges, forADCOpening New Horizons

-NewDOLCORE™The platform can bring products to marketAdvanced by one year

- ExpandedADCClinical manufacturing facilities utilize the company asADCContract OpeningManufacturing Organization (CDMO）15over the yearsExperience Drives the Next GenerationADCOpenIssue

- Increasestrengthened the company in“Three Major”Ambition for accelerated growth across business areas, including process solutions for traditional and novel drug modalities.CDMOTakeAffairs

DARMSTADT, Germany, Oct. 29, 2021 /PRNewswire/ -- Merck, a leading science and technology company, announced today that its Life Science business has introduced new technologies and expanded manufacturing capacity to advance the development of antibody-drug conjugate (ADC) therapies. These initiatives underscore Merck's continued investment in novel drug modalities and support the company's efforts to double its ADC and highly potent active pharmaceutical ingredient (HPAPI) manufacturing capacity in the near term.

Andrew Bulpin, Head of Process Solutions, Life Science at Merck, stated: “ADCs have achieved remarkable progress, with the number of commercially approved ADCs tripling over the past three years. As a pioneer in this field, we have been involved in the development of half of the commercially approved ADCs currently on the market. These latest innovations and expanded production capacity will help bring new therapies to cancer patients worldwide and reinforce our commitment to shaping the future of this novel therapeutic modality.”

With the launch of the ChetoSensar™ technology, Merck has emerged as one of the leading companies integrating CDMO services to address the hydrophobicity challenges of antibody-drug conjugates (ADCs). Many ADC candidates exhibit poor aqueous solubility, and Merck estimates that over 20% of clinical trial discontinuations for ADCs are attributable to this issue. Merck’s novel ChetoSensar™ technology enhances ADC solubility, thereby offering renewed hope for ADC candidates previously discontinued in development.

The cytotoxic payloads commonly used in ADCs are highly complex molecules that require multiple steps to synthesize. According to Merck's estimates, the new DOLCORE™ platform can significantly shorten the required development and manufacturing timelines, accelerating the time-to-market for novel Dolostatin-based ADC payloads by one year.

In addition, Merck will expand the ADC manufacturing capacity at its clinical manufacturing facility in St. Louis, Missouri, USA, in December. The facility will provide expanded space to enable large-scale production, including chromatographic purification for early clinical supplies. Prior to this, Merck last yearAnnounceAn investment of €59 million will expand the facilities near Madison, Wisconsin, USA. This initiative will double the capacity of its Class 1,000 laboratory, enabling the company to accelerate the production of HPAPIs, ADC linkers/payloads, and complex APIs.

This innovation and capacity expansion strengthen the company's ambition to accelerate growth by investing in its "three major" business pillars, including the Life Science Process Solutions business segment as a key driver.

With 15 years of experience in the development and manufacturing of antibody-drug conjugates (ADCs), Merck delivers distinctive CDMO services as a seasoned single-source provider. Leveraging its global network and deep expertise, the company tailors specialized processes for each molecule while fostering the dynamic client partnerships that pharmaceutical manufacturers require to achieve critical milestones. Merck integrates contract development and manufacturing with the industry’s broadest multi-modality portfolio. Customers can also seamlessly integrate BioReliance from the company’s leading biosafety testing portfolio.^®Service.

Merck recently announced expansion projects in Darmstadt, Germany; County Cork, Ireland; Buchs, Switzerland; Carlsbad, California; Madison, Wisconsin; Jaffrey, New Hampshire; and Danvers, Massachusetts, USA. These expansion initiatives are part of Merck’s ambitious multi-year plan to enhance industrial capacity and capabilities within its Life Science business, supporting the growing global demand for life-saving medicines and making a significant contribution to public health.

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About Merck
Merck is a leading science and technology company, operating in the healthcare, life science, and electronics sectors. Approximately 58,000 employees positively impact millions of lives every day by creating more joyful and sustainable lifestyles. From advancing gene-editing technologies and discovering unique treatments for the most challenging diseases to enabling smarter devices—Merck’s business covers every aspect. In 2020, Merck generated total sales of €17.5 billion across 66 countries.

Scientific exploration and a responsible corporate ethos have always been the key drivers of Merck’s scientific and technological progress. They are also the reason why Merck has continued to thrive since its founding in 1668. The founding family remains the majority shareholder of this 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 company’s business divisions operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics in performance materials.