BioDuro-Sundia Acquires 2nd US-based Commercial Drug Product Manufacturing Facility along with Commercial Supply Agreement

—BioDuro-Sundia to retain most employees and provide continuous supply for multiple commercial products—

SAN DIEGO–(BUSINESS WIRE)–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 fully-operational 45,000 ft2 commercial oral solid dose drug product manufacturing facility located at 9601 Jeronimo Road, Irvine, CA. As part of the acquisition, BioDuro-Sundia will employ most of the current staff and provide continuous operations to support production of multiple existing products through a commercial supply agreement. Subject to customary closing conditions, BioDuro-Sundia will assume operations on January 1, 2022.

The Jeronimo facility is located in Irvine, California on the same campus as BioDuro-Sundia’s first US-based commercial facility, announced in August 2021. The deal includes an additional 25,000 ft2 of future space with combined facilities representing ~100,000 ft2 holding a supply capacity > 4 billion doses annually. Commercial production capabilities include aqueous and organic solvent process for fluid bed and coating capabilities, amorphous solid dispersion, along with multiple high speed tableting and encapsulation machines.

“The continuity of the operation, including a highly experienced team and established processes, allows a seamless transition for commercial manufacturing in a facility with outstanding production track record and audit history,” said Alex Rodriguez, GM of the Irvine Facility at BioDuro-Sundia. “But, we are also adding new commercial-scale capabilities, such as spray dry dispersion and hot melt extrusion, which establish us as a top provider for amorphous solid dispersion manufacturing in North America.”

“The acquisition of these commercial drug production facilities is a significant milestone in our 25-year history pioneering bioavailability enhancement for oral solid dosage forms, and a credit to our team’s dedication to quality operations, client satisfaction, and growth,” said Kent Payne, who led the acquisition in his role as President, Development and Manufacturing US/EU at BioDuro-Sundia. “It is also representative of our commitment to clients across the company and the investments we continue to make to grow capacity, establish new technology, and help our partners achieve success. We look forward to supporting our commercial-stage clients with quality drug product manufacturing, as we do all of our clients who entrust us with critical programs from discovery to development to manufacturing.”

BioDuro-Sundia’s US-based clinical development facility is located only an hour drive south in San Diego, California. The development operation has a track record of 1,000+ clinical programs, specializing in solubility enhancement leveraging amorphous solid dispersions.

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 and 10 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.

For more information, visit: www.bioduro-sundia.com

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.

For more information, visit: www.adventinternational.com

About Bridgewest Business Group

Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group’s private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.

For more information, visit: www.bridgewestgroup.com

Contacts

Christina Coby

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