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Taiwan headquartered Bora Biologics, a leading contract development and manufacturing organization (CDMO) specialising in biologics manufacturing, has announced a major expansion of its US FDA-registered commercial manufacturing facility in San Diego, US.
This expansion will add state-of-the-art upstream and downstream GMP processing capabilities to meet the increasing demand for 2000L scale single-use biologics manufacturing, solidifying Bora Biologics' position as a premier biologics CDMO.
The expansion adds 8,075 square feet of state-of-the-art GMP manufacturing space to the San Diego biologics manufacturing facility, comprising a cutting-edge upstream mammalian cell culture hall, harvest suite with two inoculation rooms and in-process testing room, 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 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.
