Merck develops new technology to address solubility and speed to market challenges of ADCs – BioPharma-Reporter.com

Merck develops new technology to address solubility and speed to market challenges of ADCs – BioPharma-Reporter.com

The technology, ChetoSensar, gives new promise to ADCs by alleviating solubility challenges, said the Darmstadt, Germany headquartered operator.

Its new DOLCORE platform increases speed-to-market, it added. 

Merck outlined how those initiatives underscore its continued investment in new modalities.

“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. “This latest innovation and additional capacity help bring novel treatments to cancer patients around the world.”​

Merck, he added, is involved in 50% of the commercially approved ADCs on the market today. 

Solubility and speed to market challenges

As regards the ChetoSensar technology, Merck says it 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 the company estimates that more than 20% of ADC clinical terminations are caused by this issue.  

The payloads commonly used for ADCs are highly-complex molecules, with many steps required for synthesization. In-house calculations indicate 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.

US facility expansion 

In addition to those developments, the company said it will enhance the ADC capabilities of its clinical manufacturing facility in St Louis, Missouri, US, in December, so that it will have an expanded footprint to enable large-scale production including chromatographic purification for early phase clinical supply.

This follows last year’s announcement of a €59m (US$68.8m) expansion of Merck’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. 

Source: https://www.biopharma-reporter.com/Article/2021/10/28/Merck-develops-new-technology-to-address-solubility-and-speed-to-market-challenges-of-ADCs

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