Contract drugmaker Bioduro-Sundia is doubling up its operational presence in Irvine, as another area drugmaker exits the market.
The company, which formed a year ago after San Diego-based Bioduro and Shanghai’s Sundia merged, recently announced it is expanding operations to a second manufacturing facility in the Spectrum area of the city, near the Southern edge of the Great Park.
The newest addition, a 45,000-square-foot plant, is at 9601 Jeronimo Road.
It’s on the same campus as 72 Fairbanks, the company’s first U.S.-based commercial facility, which runs another 66,000 square feet. It announced signing a lease for that building about three months ago.
Both facilities are owned by Irvine Co.
The combined facility will grow the site’s generating capacity from 1 billion capsules and tablets per year, to over 4 billion, according to the company.
The addition also bolsters Bioduro-Sundia’s production capabilities, including aqueous and organic solvent process for fluid bed and coating capabilities, amorphous solid dispersion, and high-speed tableting and encapsulation machines, company officials said.
Financial terms of the deal were undisclosed.
Contract Research Focus
Bioduro-Sundia says it’s the third-largest contract research, development and manufacturing organization (CRDMO) in the world.
The privately held company, which is owned by private equity Advent International, reports over 160 global biopharmaceutical clients.
“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,” Alex Rodriguez, general manager of Bioduro-Sundia’s Irvine facility, said in a statement.
“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.”
In addition to its Orange County and San Diego operations, Bioduro-Sundia has 10 global research sites and GMP manufacturing facilities, predominantly in China.
The firm counts more than 2,000 global employees.
Par, Endo Ops
The buildings Bioduro-Sundia has taken over, part of Irvine Co.’s Fairbanks Industrial Park, previously served as a manufacturing plant for Par Pharmaceutical Co., long one of the larger drugmakers with operations in OC.
In November, Par’s parent company, Endo International PLC (Nasdaq: ENDP), said it would be closing its Irvine base, according to state employment filings.
Bioduro-Sundia said it will assume operations at its new Irvine plant on the first day of 2022.
The new plant “will employ most of the current staff,” said a company statement.
“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 expansion in his role as president of development and manufacturing 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.”