- Bora Biologics has expanded its U.S. drug substance manufacturing platform by adding a commercial manufacturing site in Rockville, Maryland, increasing installed U.S. single-use bioreactor capacity to 20,000 liters, scalable to 30,000 liters.
- The expanded network includes two FDA-registered facilities and is designed to support late-stage development and commercial biologics manufacturing under an integrated quality system.
Bora Biologics has expanded its U.S. drug substance manufacturing platform with the addition of a manufacturing site in Rockville, Maryland. The expansion increases the company’s installed U.S. single-use bioreactor capacity to 20,000 liters, with the ability to scale to 30,000 liters, across FDA-registered facilities in Rockville and San Diego, California. The company said the investment strengthens its BioSecure commercial platform and supports domestic CDMO manufacturing.
The combined manufacturing network comprises seven 2,000-liter commercial single-use bioreactors operating within a GMP manufacturing environment. According to Bora Biologics, the Rockville facility is actively manufacturing commercial products and supports licensed commercial programs supplying six global markets. Across its U.S. platform, the company has completed more than 200 GMP batches, including over 60 commercial batches, while achieving a 100% first-pass process performance qualification (PPQ) success rate.
“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, Chief Executive Officer of Bora Biologics
Bora Biologics said the integrated platform is designed to support programs from investigational new drug (IND) applications through biologics license applications (BLA), providing chemistry, manufacturing and controls (CMC), analytical, release, and stability support under a single quality management system. The company stated it has supported the development of more than 48 biologics and biosimilars, 74 CTA/IND submissions, four BLA filings, and completed 16 GMP technology transfers over the past five years.
The expansion is intended to strengthen Bora Biologics’ contract manufacturing capabilities for late-stage and commercial biologics programs while supporting customers seeking U.S.-based manufacturing capacity.
