BIO 2025

Bora Biologics, a CDMO specializing in biologics manufacturing, is expanding its U.S. FDA-registered commercial manufacturing facility in San Diego by adding upstream and downstream GMP processing capabilities to meet increasing demand for 2000L scale single-use biologics manufacturing.

The expansion adds 8,075 square feet of GMP manufacturing space to the San Diego biologics manufacturing facility, comprising an upstream mammalian cell culture hall, a harvest suite with two inoculation rooms and an in-process testing room, a capture suite, and a downstream processing suite. This includes 6,950 square feet of new construction and 1,125 square feet of revisions to the existing GMP space.

The expanded facility will feature two 2000L Cytiva XDR bioreactors and a seed train, providing robust and scalable biologics manufacturing services. The upstream hall’s design allows for future bioreactor expansion up to 5000L scale. The downstream process suite is engineered to efficiently process up to 5000L modern high titer cell culture processes, ensuring streamlined purification.

The San Diego facility currently offers a comprehensive range of GMP manufacturing suites, including 50L, 250L and 1000L single-use bioreactors dedicated to mammalian cell culture, and a dedicated microbial GMP suite equipped with a 150L stainless steel fermenter and a 300L single-use fermenter expansion capability. The addition of the two 2000L single-use bioreactors in 1Q26 will significantly enhance manufacturing services for seamless scale-up and commercial.

“With this expansion, we will be able to offer our customers 2000L commercial capacity with the ability to purify modern high-titer cell culture processes,” said John R. Mosack, General Manager & Vice President, Operations of the San Diego Site at Bora Biologics. “In addition to the two 2000L Cytiva bioreactors we are installing now, we will have the space to grow with our customers and meet their evolving needs.”

cGMPnow, a provider of GMP facility design and GxP systems implementation and compliance for the biopharmaceutical industry, is providing process equipment, clean utilities, and automation/controls engineering and commissioning, qualification, and validation expertise for this expansion project. Cytiva is supplying the advanced bioreactor technology for the expanded facility. DPR Construction, a technical builder, is applying its skills and experience to the construction of the expanded facility.