Veranova, a global leader in the development and manufacturing of specialist and complex APIs for the pharmaceutical and biotech sectors, announced initiation of a significant expansion of its antibody-drug conjugate (ADC) and highly potent compound development and manufacturing capabilities at its Devens, MA facility. The estimated $30 million investment will build upon the site’s existing development and manufacturing capabilities and will address the growing demand for strong US-based capacity for ADCs and other potent small molecules.
The expansion will include a new high potent process development laboratory and two new cGMP suites designed to handle potent compounds with occupational exposure limits (OEL) of less than 0.01 µg/m³. These facilities, equipped to manage high-potency compounds, ADC linker-payloads, and other complex molecules, will feature dedicated air handling systems, airlocks for clean-in-place operations, isolator technology, and a comprehensive range of processing capabilities, including synthesis reactors, chromatography, thin film evaporators, and lyophilization.
“At Veranova, we recognize the growing demand for development and manufacturing of ADCs and other highly potent compounds,” said Mike Riley, CEO of Veranova. “This investment signals our commitment to providing state of the art capacity and capabilities to enable these next generation therapies to reach patients, and is a key milestone as we advance our broader growth strategy for Veranova.”
Strategically located near the Boston pharmaceutical and biotech hub, Veranova’s Devens site is an FDA-approved facility that boasts over 10 years of experience in the development, scale-up, and clinical and commercial production of ADC linker-payloads and other highly potent APIs. Uniquely positioned to perform development, clinical manufacturing, and commercial manufacturing all under one roof, the Devens facility eliminates the need for tech transfers and leverages Veranova’s leading capabilities in both crystallization development and chromatography.
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