Bora Biologics completes 2,000L scale-up run at new US site

Bora Biologics announced completion of its first 2,000-liter engineering scale-up and process confirmation run at its FDA-approved facility in San Diego, California. According to the company, the run validated operational readiness of the expanded mammalian manufacturing suites and confirmed integrated upstream, downstream, and quality systems at commercial scale.

The campaign included scale-up of the TX05 trastuzumab biosimilar process from 1,000 liters to 2,000 liters. Bora Biologics said the run demonstrated the site’s ability to support licensure-stage manufacturing at larger batch volumes and highlighted its capabilities in technology transfer and process scale-up.

The San Diego facility expansion, completed in January 2026, represented a $30 million investment designed to support late-stage clinical supply, process performance qualification campaigns, and commercial manufacturing. The site supports single-use bioreactor capacity from 500 liters to 2,000 liters and is designed to accommodate future 5,000-liter configurations.

Bora Biologics also said its San Diego drug substance operations are integrated with sterile fill-finish capabilities at Bora Pharmaceuticals’ FDA-approved facility in Baltimore, Maryland, providing a domestic manufacturing network for biologics sponsors.

According to the announcement, the successful run follows the company’s recent TX05 resubmission filing and reflects increasing demand for U.S.-based biologics manufacturing capacity as companies reevaluate global supply chain strategies.