PHARMA TECH

Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, 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 Merck'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.

"ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe 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.

Andrew Bulpin, head of Process Solutions, Life Science, at Merck
 

With the launch of its ChetoSensar™ technology, Merck 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 Merck 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 Merck'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, 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 €59 million expansion of Merck's facility near Madison, Wisconsin, USA, 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 Three," 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, Merck 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. Merck 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. 

Merck 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.

About Merck
Merck, 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 generated sales of € 17.5  billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the 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 business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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A five day executive course on Quality by Design (QbD). QbD is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing great emphasis on the QbD component as a part.

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Xencor, Zenas BioPharma | November 22, 2021

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Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to the development of obexelimab as a potential treatment for patients with autoimmune diseases; the commercial potential of obexelimab; the safety, tolerability, efficacy and pharmacokinetics of obexelimab; the quotations from Xencor’s president and chief executive officer; and other statements that are not purely statements of historical fact. 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