Bora Biologics is expanding its FDA-registered manufacturing site in San Diego to support growing demand for 2,000L-scale biologics production.
The build-out adds 8,075 square feet of GMP manufacturing space, including upstream and downstream processing areas, and prepares the facility to scale up to 5,000L in the future. The expansion includes 6,950 square feet of new construction and 1,125 square feet of updates to existing space.
The upgraded facility will incorporate two 2,000L Cytiva XDR bioreactors and associated seed train, supporting high-titer cell culture processes. The downstream suite is designed to accommodate processing of up to 5,000L batches, offering clients scalability for commercial manufacturing. Bora currently operates single-use bioreactors at 50L, 250L, and 1,000L capacity, along with microbial fermentation capacity up to 300L.
The project is supported by cGMPnow, which is overseeing process equipment installation, clean utilities, automation, and validation. Cytiva is supplying the bioreactors, while DPR Construction is leading the site build-out. The additions are expected to be operational in Q1 2026.
Bora Biologics says the expansion strengthens its position as a full-service biologics CDMO and enhances its ability to offer seamless scale-up capabilities across mammalian and microbial platforms.