Life Sciences
BioDuro-Sundia Completes First GMP Drug Product Manufacturing at New China Site
13 April 2021
SAN DIEGO and SHANGHAI, April 13, 2021 – BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today it has successfully completed its first GMP drug product clinical batch manufacturing at the company’s new R&D center in Wuxi, China. The production received a perfect score within the company’s quality system, with zero corrective and preventative actions, initiating the site’s 60 million unit production capacity for oral dosage forms, including tablets and capsules.
"This is a major quality milestone for our development and manufacturing capacity in China. We have implemented a full quality system, requiring all departments—manufacturing, quality, project management, and local operations—to work together and adhere to defined set of operating procedures," said Haijun Dong, PhD, Global CEO for BioDuro-Sundia. "This achievement confirms the quality culture of BioDuro-Sundia and it gives our Wuxi facility the GMP capacity needed to support our clients from discovery all the way through manufacturing."
BioDuro-Sundia’s R&D Wuxi site opened in September of 2020 as a fully integrated facility. The site covers an area of 30,000m2, including chemistry, biology, DMPK, pharmacology and 2,000m2 dedicated to GMP manufacturing.
"The opening of our new Wuxi site has received tremendous support from the R&D park, the Huishan district and Wuxi municipal government, for which we are very grateful," added Dong. "The new site will be one of the major engines for our next phase of growth."
"We are very optimistic about the future of our Wuxi R&D center," said Jim Li, PhD, President of Global CMC Solutions, China for BioDuro-Sundia. "We will continue to invest and grow our GMP production capability to support future programs, allowing us to help our pharma partners develop new medicines for patients in need."
The new capability joins the company’s existing drug product manufacturing facility based in San Diego, which has 25 years of manufacturing and audit history (including FDA). Together, BioDuro-Sundia’s drug product manufacturing capacity now exceeds 220 million tablets and 50 million capsules, supporting Phase I-III clinical studies across the globe, including US and China. GMP manufacturing is compliant with FDA and NMPA regulations and supports >95% of all solid oral dosage forms, including: poorly soluble APIs, pediatric formulations, high potency formulations, and hygroscopic and photosensitive products.
About BioDuro-Sundia
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.
BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.
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About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.
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SOURCE: BioDuro-Sundia