Bora Biologics announced it has expanded its U.S. biologics manufacturing network with the addition of its Rockville, Maryland facility, increasing the company’s installed single-use drug substance manufacturing capacity to 20,000 liters across FDA-registered sites in Maryland and California.

Earlier this month, Bora Pharmaceuticals completed its $122.5 million acquisition of MacroGenics’ GMP manufacturing operations, which includes the Rockville biologics drug substance facility and a warehousing center in Frederick, Maryland. Following the acquisition, Bora signed a long-term CDMO services agreement with MacroGenics and said it plans to integrate the Rockville drug substance operation with its existing sterile drug product manufacturing capabilities over the next 12 to 18 months.

The Rockville site supports commercial biologics manufacturing and includes seven 2,000-liter single-use bioreactors operating within a single-use GMP manufacturing platform. According to the company, the facility is manufacturing commercial products and supplies licensed biologics to multiple global markets.

Bora Biologics said its 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 company also provides chemistry, manufacturing and controls (CMC), analytical, release testing, stability, and technology transfer services to support biologics programs from development through commercial manufacturing.

“This expansion strengthens our ability to support late-stage and licensed programs within an inspection-proven, U.S.-anchored infrastructure. As regulatory and policy environments increasingly prioritize secure domestic manufacturing, Rockville enhances our ability to deliver predictable launch execution with regulatory durability,” Stephen Lam, CEO of Bora Biologics, said in a statement.

“By expanding to 20,000 liters of U.S. single-use capacity across commercially active sites, we are strengthening our ability to capture and retain late-stage programs while reducing lifecycle risk for our partners,” added Chief Commercial Officer Marc Goemans.