Bora has maintained a rapid pace of growth over the last decade, achieving a 40% compound annual growth rate (CAGR) since 2016. Importantly, this growth isn’t just about acquiring sites and increasing capacity. We have also invested substantially in enhancing capabilities across our global network to better serve clients.
Part of this investment is a substantial expansion in North America, including roughly $400 million invested over the past two years in U.S. facilities for both large and small molecules. According to Bobby Sheng, CEO of Bora Pharmaceuticals, this level of investment in U.S. small-molecule drug production makes Bora unique among CDMOs. The U.S. market accounts for roughly 80% of Bora’s business and the majority of our 2,600 global employees.
Driving these decisions is a focus on creating supply chain resilience. Adding capacity in the current environment of tariffs and onshoring is a strategic step toward creating an integrated network that facilitates customers’ paths from development to commercialization.
Building an integrated U.S. biologics network
Recent investments have significantly expanded Bora’s U.S. biologics footprint. The acquisition of MacroGenics’ GMP manufacturing operations in Rockville, Maryland, adds commercial biologics manufacturing capacity to a network that also includes drug substance manufacturing in San Diego, California, and development capabilities in Zhubei, Taiwan. Together, Bora Biologics’ Rockville and San Diego facilities provide 20,000 L of single-use bioreactor drug substance capacity.
The Rockville site includes five 2,000 L and two 500 L single-use bioreactors, while a recently completed $30 million expansion in San Diego supports late-stage clinical supply, process performance qualification campaigns, and commercial manufacturing. The San Diego site offers single-use capacity from 500 L to 2,000 L, with the potential for future 5,000 L configurations. It is also integrated with sterile fill-finish capabilities at Bora’s Baltimore, Maryland, facility, providing greater continuity between drug substance and drug product manufacturing.
Single-use technology is central to this strategy, offering the flexibility to accommodate different production requirements while reducing cross-contamination risks and simplifying cleaning requirements. “We’re big proponents of single-use technology,” Sheng says. “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.”
Bora recently completed its first 2,000 L engineering scale-up and process confirmation run at the expanded San Diego facility, demonstrating operational readiness across upstream, downstream, and quality systems at commercial scale.
These capabilities are backed by an established track record of manufacturing excellence. Across Bora’s U.S. biologics network, our teams have completed more than 200 GMP batches, including more than 60 commercial batches, and supported more than 48 biologics and biosimilars, 74 clinical trial and investigational new drug applications, and four biologics license applications. Combined with CMC, analytical, release testing, stability, and technology transfer services, this infrastructure enables us to support biologics programs as they progress from development into commercial manufacturing.
Exploring the next generation of pharmaceutical development
Investment in Bora’s network extends beyond physical manufacturing capacity. We are also exploring how emerging technologies can strengthen the connection between drug development and manufacturing. A recently announced potential $2.5 billion collaboration with Insilico Medicine will evaluate opportunities to integrate artificial intelligence (AI) and automation-driven approaches into drug development planning, process optimization, manufacturing, and quality execution.
For Bora, adopting AI is not about replacing established pharmaceutical development and manufacturing practices. Instead, the goal is to understand where these tools can meaningfully improve decision-making and efficiency while maintaining the rigorous processes required for pharmaceutical manufacturing. As these capabilities mature, they could contribute to a more connected platform spanning development through commercial production.
Expanding oral solid dose capabilities
Small-molecule manufacturing remains another major focus of our investment strategy. Oral solid dosage (OSD) products continue to represent a significant portion of pharmaceutical demand, while advances in formulation and processing technologies are enabling increasingly complex molecules to be delivered through oral dosage forms. In response, Bora has invested hundreds of millions of dollars in large-scale OSD manufacturing, including continued investment in our Maple Grove, Minnesota facility, where we are building out more than 100,000 square feet of additional manufacturing and packaging space.
The value of this capacity is increasingly evident across both clinical and commercial programs. Bora recently entered a manufacturing agreement with Onconic Therapeutics to produce and package clinical trial supplies for a planned U.S. Phase 3 study. In addition to manufacturing at Maple Grove, we will provide quality control, stability testing, and CMC documentation to support the clinical program.
Our long-standing relationship with GSK provides another example of how an integrated network can support evolving customer needs. In February, Bora renewed a five-year manufacturing partnership with GSK valued at $250 million. Commercial production will continue at our Mississauga, Ontario, facility, which Bora acquired from GSK in 2020, while the agreement also gives GSK access to multiple facilities across Bora’s network, including Maple Grove.
For customers, the goal behind these investments is ultimately broader than adding individual pieces of equipment or manufacturing capacity. As pharmaceutical companies seek partners capable of supporting a wider range of modalities, development stages, and geographic supply needs, we continue to evolve our network to meet these needs. “We continue to invest in scope and scale,” says Sheng. “Our customers are getting larger. They have more breadth of scope for different needs in the CDMO space.” By connecting development expertise with drug substance, drug product, and commercial manufacturing capabilities, we are building the infrastructure to support programs throughout their lifecycle while providing the reliability and continuity customers need as they grow.