Merck expands technology and capacity for ADC manufacturing

1-Nov-2021

“ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three years”

Merck KGaA has updated its technology and expanded its capacity to advance ADC therapies. These initiatives are part of a continued investment in novel modalities and support the company’s efforts to double its ADC and HPAPI capacity in the near future.

“ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three years,” said Andrew Bulpin, head of Process Solutions, Life Science, at Merck. “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, the company aims to address to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and the company estimates more than 20% of ADC clinical terminations are caused by this issue. The ChetoSensar reportedly technology improves ADC solubility to address this problem.

The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesise. Merck’s 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, the company claims.

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In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, 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 €59m expansion of the company’s Wisconsin, USA facility, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.

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