Bora Biologics Expands U.S. Commercial Manufacturing Platform with Addition of Rockville Site

Bora Biologics, a U.S.-based biologics CDMO engineered for licensed supply, announced the expansion of its U.S. drug substance manufacturing platform through the addition of the Rockville, Maryland site. The addition strengthens the company’s U.S.-anchored BioSecure commercial platform and reinforces its long-term investment in domestic biologics manufacturing.

The Rockville site is actively manufacturing commercial product and supports licensed commercial programs supplying six global markets. Across the combined U.S. platform, Bora Biologics has executed more than 200 GMP batches, including over 60 commercial batches, with 100% first-pass PPQ success.

The company has supported the development of more than 48 biologics and biosimilars, 74 CTA/IND submissions, and four BLA filings, completing 16 GMP tech transfers within the past five years.

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

The integrated platform operates with mature QMS systems refined through multiple regulatory inspections and provides end-to-end CMC, analytical, release, and stability support from IND through BLA.

“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 Marc Goemans, Chief Commercial Officer. “Rockville advances the depth, reliability, and long-term durability of our commercial platform.”