Taiwan-headquartered contract development and manufacturing organization (CDMO) Bora Pharmaceuticals continues to grow at a blistering pace. The company has achieved a compound annual growth rate of 40% every year since 2016, according to CEO Bobby Sheng, who launched the company in 2007 with the goal of becoming a world-class CDMO.

“We’ve been really fortunate to sow the seeds over the last four to five years for the expansion in North America,” Sheng told Pharma Manufacturing. “We’re probably one of the few small-molecule CDMOs that have invested in U.S. manufacturing.”

Over the last two years, Bora has invested approximately $400 million in U.S. facilities for both large and small molecules. Going forward, the company has earmarked $600 million for future investment in North America.

Sheng emphasized that adding capacity in the current environment of tariffs and onshoring is about creating an integrated network that enables customers to move from development to commercialization, while noting that the U.S. market represents about 80% of Bora’s business and is home to most of the company’s 2,600 employees.

“All of our investments are focused on working with our partners and creating supply chain resilience,” Sheng said. “Regionally, it’s been highly focused on the U.S.”

Biologics sites in Maryland and California

Last month, Bora completed its $122.5 million acquisition of the GMP manufacturing operations of MacroGenics, including a biologics drug substance manufacturing facility in Rockville, Maryland. The purchase expands wholly owned subsidiary Bora Biologics’ U.S. manufacturing network to 20,000 liters of single-use bioreactor drug substance capacity across facilities in Rockville and San Diego, California, along with a development site in Zhubei, Taiwan.

“On the large molecule side, we’re seeing a lot more investment from the biobucks that are coming back,” Sheng said. “We’re the benefactors of our last two investments in mid-scale commercial biologics in the U.S., with San Diego and our recent facility in Rockville.”

The Rockville site supports commercial biologics manufacturing and includes seven 2,000-liter single-use bioreactors operating within a single-use GMP manufacturing platform.

The San Diego facility expansion, completed in January, represents a $30 million investment designed to support late-stage clinical supply, process performance qualification campaigns, and commercial manufacturing.

Bora’s San Diego drug substance site, with single-use bioreactor capacity from 500 liters to 2,000 liters and the option of future 5,000-liter configurations, is integrated with sterile fill-finish capabilities at the company’s 87,000-square-foot facility in Baltimore, Maryland.

“We’re big proponents of single-use technology,” Sheng commented. “It creates safer environments eliminating cross-contamination. The FDA likes it. The cleaning requirements are better. Also, the flexibility is there for single runs and multiple runs.”

In April, Bora completed its first 2,000-liter engineering scale-up and process confirmation run at the San Diego facility, validating operational readiness of the expanded mammalian manufacturing suites and confirming integrated upstream, downstream, and quality systems at commercial scale.

Bora’s combined U.S. manufacturing network has completed more than 200 GMP batches, including more than 60 commercial batches, and has supported the development of more than 48 biologics and biosimilars, 74 clinical trial and investigational new drug applications, and four biologics license applications.

The CDMO provides chemistry, manufacturing and controls (CMC), analytical, release testing, stability, and technology transfer services to support biologics programs from development through commercial manufacturing.

“We are able to provide an end-to-end solution for our customers,” Sheng said.

Last month, Bora announced a potential $2.5 billion collaboration with Insilico Medicine to explore integrating artificial intelligence (AI) with pharmaceutical development and manufacturing. The partnership will evaluate AI-driven approaches for drug development planning, process optimization, manufacturing readiness, and quality systems across the product development lifecycle.

“From a manufacturing perspective, we just need to be respectful of the current processes and we also need to be careful on how we move forward, but we are heavily investing in knowledge of understanding about AI,” Sheng commented. “What I’m excited about is for us to build a complete end-to-end platform that utilizes AI.”

Oral solid dose investment

On the customer side, the CDMO in February renewed a five-year manufacturing partnership with GSK valued at $250 million, with commercial production continuing at Bora’s Mississauga, Ontario facility — which Bora acquired from the drugmaker in 2020. Under the agreement, GSK will have access to multiple sites within Bora’s global network, including its oral solid dose (OSD) facility in Maple Grove, Minnesota.

“It’s an evolution of our relationship [with GSK],” Sheng said. “They took a chance on us to allow us to buy their facility in Mississauga. It’s a very large facility that required a lot of CAPEX. They entrusted us with seamless integration, continuity of supply, and 400 employees.”

Last month, Bora also announced a manufacturing agreement with South Korea-based Onconic Therapeutics to produce clinical trial supplies for its tablets as the company prepares for a planned U.S. Phase 3 study in patients with gastroesophageal reflux disease.

Bora’s 100,000-square-foot OSD manufacturing facility in Maple Grove will manufacture and package the clinical trial drug product, while also providing quality control, stability testing, and CMC documentation to support the U.S. clinical program.

“We’ve invested hundreds of millions of dollars into large-scale OSD manufacturing,” said Sheng, who described the Maple Grove facility as one of the largest OSD sites built in the U.S. over the past decade. “The majority of the demand and the most efficient way to deliver drugs is still oral solid dose. It’s the most stable and with new technologies coming out there’s a lot of different drugs that are still being developed.”

“We continue to invest in scope and scale,” he added. “Our customers are getting larger. They have more breadth of scope for different needs in the CDMO space.”