Pharma Focus Asia

BioDuro-Sundia Acquires US-based Phase III/Commercial Drug Product Manufacturing Facility

Tuesday, August 24, 2021

BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today it has entered into a definitive agreement to acquire a 40,000 ft2 commercial oral solid dose manufacturing facility located at 72 Fairbanks, Irvine, CA, USA. Subject to customary closing conditions, BioDuro-Sundia expects to begin commercial service operations at the site on January 1, 2022.

“This fully-audited and operational facility allows us to immediately support our clients who require larger scale commercial production,” said Kent Payne, who led the acquisition in his role as President, Development and Manufacturing US/EU at BioDuro-Sundia. “BioDuro-Sundia is a pioneer in enhancing bioavailability, with 25 years of experience applying stabilized amorphous solid dispersion technology to poorly soluble drug product candidates. Our clients have requested our support to provide commercial scale manufacturing to save time and maximize success, and it is a pleasure to take this next step with them.”

Capabilities of the new site include > 1-billion-unit annual capacity in tableting and encapsulation, as well as aqueous and organic solvent process for fluid bed and coating capabilities.

BioDuro-Sundia is immediately making new equipment investments in support of the commercial operation, including commercial Spray Drying capacity up to 100Kg/hr and Hot Melt Extrusion capacity up to 30Kg/hr. These capabilities provide a commercial extension to the company’s existing oral solid development and manufacturing capabilities.

“We are dedicated to our clients through all phases of drug discovery, development and manufacturing,” said Payne. “This means continued investment in our capabilities as we have done at our new 150,000 ft2 R&D site in Wuxi City last year, and now our US-based commercial drug product manufacturing site. In partnership with our investors, Advent International, we are committed to accelerating growth to support clients from discovery through to commercialization. The results are good for all stakeholders, and especially critical for our pharma partners who benefit from integrated services with time savings and quality drug product.”

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