Bora Biologics, a leading contract development and manufacturing organization specializing in biologics manufacturing, announced a major expansion of its U.S. FDA-registered commercial manufacturing facility in San Diego. The expansion will add state-of-the-art upstream and downstream GMP processing capabilities to meet increasing demand for 2000L scale single-use biologics manufacturing, solidifying the company's position as a premier biologics CDMO.
Facility Expansion Details
The expansion adds 8,075 square feet of state-of-the-art GMP manufacturing space to the San Diego biologics manufacturing facility. The new space comprises 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 clients with robust and scalable biologics manufacturing solutions. The upstream hall's design allows for future bioreactor expansion up to 5000L scale, while the downstream process suite is engineered to efficiently process up to 5000L modern high-titer cell culture processes, ensuring streamlined purification.
Enhanced Manufacturing Capabilities
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 the company's 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."
Miguel Carrion, Vice President, Process Development and MS&T at Bora Biologics, added, "With the addition of the new Cytiva trains, we now have the ability to offer customers both Fisher Single Use and Cytiva Single Use bioreactor trains, providing greater flexibility and options for their specific manufacturing requirements."
Strategic Partnerships
cGMPnow, a leading 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. Jeff Gilmore, CEO of cGMPnow, expressed enthusiasm for the partnership, stating, "We are absolutely thrilled to be partnering with Bora Biologics on this critical expansion, leveraging our expertise in biopharmaceutical engineering and cGMP compliance to deliver a state-of-the-art facility that will enable their clients to reach more patients."
Cytiva is supplying the advanced bioreactor technology for the expanded facility. Jordan Heard, Americas Upstream and Consumable Leader (USA) at Cytiva, stated, "Cytiva is proud to support Bora Biologics in their commitment to innovation and growth. Our XDR bioreactors will provide Bora Biologics with the scalability and flexibility needed to meet the evolving demands of the biologics market."
DPR Construction is handling the construction of the expanded facility. Scott Sass, DPR's San Diego Business Unit Leader, shared his excitement about the project: "DPR is excited to partner with Bora Biologics on this project, bringing our expertise in advanced biomanufacturing facility construction to help them expand their capabilities and serve their clients."
Company Background
Bora Biologics is a global CDMO offering comprehensive end-to-end solutions for biopharma companies worldwide. With a proven track record of over 100 successful cGMP manufacturing batches, the company leverages its state-of-the-art, FDA-registered facility in the U.S. and deep expertise in biologics development and manufacturing, including its own FDA-licensed and Health Canada-approved product, to enhance time and cost efficiencies while ensuring effective pathways to market for its clients. Bora Biologics combines innovative early-phase development and late-stage manufacturing capabilities with the expertise and reputation of Bora Pharmaceuticals for flexible and scalable fill/finish services, including stability testing, and final packaging of clinical and commercial products.
