Biologics contract development and manufacturing organisation (CDMO) Bora Biologics is to expand its FDA-registered commercial manufacturing facility in San Diego.
Through the expansion, Bora Biologics will add 8,075 sqft of additional GMP manufacturing space, offering up and downstream processing capabilities.
This includes a mammalian cell culture hall, a harvest suite with two inoculation rooms plus an in-process testing room, as well as a capture and downstream processing suite.
The newly renovated facility will feature two 2000L Cytiva XDR bioreactors and seed train, allowing Bora's customers to effectively scale their manufacturing processes.
Bora Bioloigcs has also designed the upstream hall to allow for future bioreactor expansion up to the 5000L scale.
The downstream process suite is engineered to efficiently process up to 5000L modern high-titer cell culture processes, ensuring streamlined purification.
The company is also planning to add two 2000L single-use bioreactors early in 2026,
Bora Biologics' San Diego facility currently offers a wide 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 company is also planning to add two 2000L single-use bioreactors early in 2026, allowing for further scale-up.
"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 & VP, 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."
This expansion was done in tandem with cGMPnow, a provider of GMP facility design and GxP sytems implementation for biopharmaceutical partners.
Cytiva is supplying the advanced bioreactor technology for the expanded facility. Emphasising Cytiva's support for Bora Biologics' growth, 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."
[Image credit: Bora Biologics]