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Will add upstream and downstream GMP processing capabilities to meet increasing demand for 2000L scale single-use biologics manufacturing.
May 22, 2025
By: Charlie Sternberg
Bora Biologics, a contract development and manufacturing organization (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 Bora Biologics’ clients with robust and scalable biologics manufacturing solutions. 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.
Bora Biologics’ 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 planned addition of the two 2000L single-use bioreactors in Q1 2026 will significantly enhance Bora Biologics’ ability to provide seamless scale-up and commercial manufacturing solutions to its clients.
“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.
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