MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, has launched new technology and expanded capacity to advance ADC therapies. MilliporeSigma continues to invest 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.
 
“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 is designed to improve 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, MO 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, WI, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.