BioDuro-Sundia, a drug discovery and development services organization, has acquired a 40,000 square foot commercial oral solid dose manufacturing facility located at 72 Fairbanks, Irvine, CA. 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, 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 more than 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 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 square foot R&D site in Wuxi City, China last year, and now our U.S.-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.”