BioDuro-Sundia Brings Manufacturing to Irvine

Joins Dendreon, Avid Bioservices

Drugmaker BioDuro-Sundia, which bills itself as the third-largest contract research, development and manufacturing organization (CRDMO) in the world, says it is expanding into Orange County with a new facility in the Irvine Spectrum area, the latest sign of growth in the local drug development industry.

The company, created a year ago by the combination of San Diego-based Bioduro and Shanghai’s Sundia, said last month it had entered into an agreement to take over Irvine’s 72 Fairbanks, a 66,000-square-foot manufacturing facility near the southern edge of the Orange County Great Park.

The facility, with roughly 40,000 square feet of manufacturing space, would be the com

pany’s only U.S. location outside

San Diego, according to BioDuroSundia’s website.

The building is part of Irvine Co.’s nearly 295,000-square-foot Fairbanks Industrial Park.

A news release by BioDuro-Sundia suggested it would be buying the building from Irvine Co.—marking a rare property sale for the Newport Beach landlord—though a price was not cited.

Real estate sources suggest a lease, rather than a sale, is more likely for the facility.

BioDuro-Sundia said it expects to begin commercial service operations at the site at the start of next year.

1 Billion Tablets

The building previously served as a manufacturing plant of Par Pharmaceuticals Co., which ranks No. 6 on this week’s Business Journal list of the largest drugmakers in Orange County by employee count.

Par Pharmaceuticals and its parent company Endo International PLC (Nasdaq: ENDP) are estimated by the Business Journal to employ about 160 people here. The company counts another 41,000-square-foot facility nearby in the Spectrum area.

BioDuro-Sundia currently has a workforce of 2,000, as well as 10 research and manufacturing sites, primarily in China.

It recently opened a new, 150,000-square-foot R&D facility in China’s city of Wuxi, officials said.

Its “one-stop-shop operation” accelerates the discovery and development of high-quality and FDA-compliant drugs for its biopharma partners across the globe, officials say.

“This fully-audited and operational facility allows us to immediately support our clients who require larger scale commercial production,” Kent Payne, president of BioDuro-Sundia’s development and manufacturing operations in the U.S. and Europe, said in a statement.

Officials said the Irvine facility should allow the contract drug developer to ramp up large scale production, to the tune of 1 billion oral tablets and drug capsules per year.

BioDuro-Sundia is backed by private equity firms Advent International and Bridgewest Business Group.

“In partnership with our investors,

Advent International, we are committed to accelerating growth to support clients from discovery through to commercialization,” Payne said. “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.”

Dendreon’s Pivot

BioDuro-Sundia’s lease of the Irvine building comes amid a busy period for local contract manufacturers, several of which place high on this week’s drugmakers list.

In June, the Business Journal reported on Seal Beach’s Dendreon Pharmaceuticals LLC unveiling a contract manufacturing and patient services division, to leverage its expertise in cellular immunotherapy.

The new division makes Dendreon one of four companies offering cell therapy manufacturing for commercial use in the U.S., officials said at the time.

“Innovative cell therapies have the potential to change how we treat serious diseases, but there is currently insufficient capacity to meet anticipated industry demand,” Chief Executive Jason O’Neill said in June.

Dendreon ranks No. 4 on this week’s list, with an estimated 190 local workers.

O’Neill joined Dendreon in mid-2020, tasked with improving commercial operations and building a second revenue stream. He was previously chief executive of breast cancer drugmaker Iridium Therapeutics and led Sanofi’s oncology portfolio for about six years, among other roles.

O’Neill said it quickly became apparent that Dendreon’s manufacturing division was a “hidden asset that was widely underutilized.”

The company’s Seal Beach headquarters— which runs about 180,000 square feet—will be the contract manufacturing services hub. Meanwhile, a Seattle facility the company uses will serve as the process development and manufacturing services center.

Avid in Overdrive

Dendreon’s recent pivot is like that of Tustin’s Avid Bioservices Inc. (Nasdaq: CDMO), which made the decision to focus on contract manufacturing in 2018.

The move’s proved to be a successful one. Avid’s shares have skyrocketed more than 200% over the past year, to a value approaching $1.5 billion.

It’s been grabbing more work; during fiscal 2021, Avid signed new business orders for approximately $148 million as compared to $80 million during fiscal 2020. Recent wins include serving as the commercial manufacturer for the humanized monoclonal antibody portion of Zynlonta, a recently approved cancer treatment developed by Switzerland’s ADC Therapeutics.

Avid is amid an expansion to its local facilities along Myford Road to handle even more work. That expansion is expected to cost between $60 million and $70 million, according to regulatory filings.

Once completed, those facilities “will result in a total revenue generating capacity of up to $270 million annually depending on the mix of products,” Avid said in its latest annual report.

Avid ranks No. 3 on this week’s list with about 250 local employees; officials said in the company’s latest earnings call that it expects to go on a hiring spree to accommodate its expanded operations.