Darmstadt, Germany, September 10, 2020 /PRNewswire/ -- Leading science and technology company Merck today announced a €59 million investment to expand high-potency active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate (ADC) manufacturing capacity at its facility near Madison, Wisconsin, USA. This investment will support large-scale production of potent compounds for therapies with anticancer potential. The expansion is expected to be completed by mid-2022 and will create approximately 50 new full-time positions starting in 2021.
Andrew Bulpin, Head of Process Solutions at Merck Life Science, stated: “ADCs have experienced remarkable growth over the past decade, with recent regulatory approvals underscoring their promise as targeted therapies. With over 35 years of experience in this field, we have been at the forefront of the development and manufacturing of biologics, conjugation processes, and small molecules. This investment reflects our commitment to collaborating with innovators to deliver new therapies to patients more rapidly and effectively.”
Merck’s newly constructed 6,500-square-meter commercial building will become one of the largest dedicated HPAPI facilities, specifically designed to handle materials with occupational exposure limits at the single-digit nanogram level. This project is an addition to the company’s Madison site, which is the first commercial ADC facility in North America for handling highly potent materials. The new building will join Merck’s site in St. Louis, Missouri, USA, which specializes in ADC bioconjugation and the production of active pharmaceutical ingredients (APIs) and excipients.
Antibody-Drug Conjugates (ADCs) are an emerging class of therapeutics that deliver highly specific, targeted cytotoxic effects to cancer cells while sparing healthy cells. Currently, only nine ADCs have been approved worldwide. Nevertheless, the ADC industry is experiencing robust growth and is projected to reach €13 billion by 2030¹.
Although antibody-drug conjugates (ADCs) offer many advantages over other treatment regimens, they also present unique challenges. ADC development is complex, requiring stringent containment infrastructure, and their structural intricacies demand expertise in numerous technical aspects of both small-molecule and large-molecule modalities, as well as robust analytical capabilities. Due to these challenges, more than 70% of ADC projects are outsourced to contract development and manufacturing organizations (CDMOs)².
Merck has over 35 years of experience in the development and manufacturing of small molecules, biologics, and antibody-drug conjugate (ADC) technologies, along with extensive expertise in clinical and commercial manufacturing. The company’s comprehensive service portfolio integrates drug development and production steps—from preclinical to commercial stages. This integration helps mitigate risks and streamlines the process of delivering therapies to patients more rapidly.
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