News | June 28, 2024

CDMO Veranova Announces Significant Investment For ADC And Highly Potent API Capabilities At Massachusetts Facility

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Wayne, PA – Veranova, a global leader in the development and manufacturing of specialist and complex APIs for the pharmaceutical and biotech sectors, today 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.

About Veranova
Veranova is a global leader in process development and the manufacturing of APIs, with a focus on specialty and complex products. Veranova is headquartered in Wayne, PA and has operations in North America and Europe.

About Veranova’s Drug Conjugate Capabilities
Veranova offers extensive capabilities from early development through commercial GMP manufacturing, handling highly potent compounds up to SafeBridge® category 4. The company has experience with multiple linker-payload systems and diverse types of polymers, including PEGs, polyesters, polyamides, polysaccharides, and polypeptides. Veranova’s extensive chromatography capabilities and techniques for molecular weight distribution (MALS/GPC/SEC) are complemented by diafiltration/tangential flow filtration (TFF) and reverse osmosis, as well as lyophilization capabilities.

Learn more about Veranova’s drug conjugate capabilities.

About Veranova’s Devens Facility
Veranova’s Devens, MA, facility delivers tailor-made solutions to partners in the pharma and biotech sectors. The Devens facility boasts extensive development and cGMP laboratories, clinical and commercial kilo labs, and multi-purpose production suites.

Learn more about Veranova’s facilities.

Source: Veranova