MilliporeSigma Announces New Innovation & Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

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Oct 28, 2021, 09:00 ET

- MilliporeSigma's unique technology, ChetoSensar™, gives new promise to ADCs by alleviating solubility challenges

- New DOLCORE™ platform increases speed-to-market by up to a year

- Expanded ADC clinical manufacturing facility drives next generation ADCs, building on company's 15 years of ADC Contract Development Manufacturing Organization (CDMO) experience

- Reinforces company's ambition to accelerate growth in "Big Three" businesses, including its Process Solutions' CDMO services for traditional and novel modalities

BURLINGTON, Mass., Oct. 28, 2021 /PRNewswire/ -- MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore MilliporeSigma's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future.

MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, launches new technology and expands capacity to advance antibody-drug conjugate (ADC) therapies.

"ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three years," said Andrew Bulpin, head of Process Solutions at the Life Science business of Merck KGaA, Darmstadt, Germany. "We are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities."

With the launch of its ChetoSensar™ technology, MilliporeSigma is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and MilliporeSigma estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated.

The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on MilliporeSigma's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year.

In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a $65 million expansion of MilliporeSigma's facility near Madison, Wisconsin, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.

This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big 3", including the Process Solutions business unit within the Life Science business sector as a key driver.

With 15 years of experience developing and manufacturing ADCs, MilliporeSigma offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. MilliporeSigma integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance^® services from the company's leading biosafety testing portfolio.

MilliporeSigma recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health.

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About the Life Science business of Merck KGaA, Darmstadt, Germany

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 23,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany generated sales of € 17.5 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit www.emdgroup.com.

SOURCE MilliporeSigma