Bracco Imaging announced an upgrade of its manufacturing site in Geneva to support clinical-grade GMP manufacturing of its cell therapy-enabling microbubble technology, building on its previously announced Investments in the site since 2019.
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Geneva
Commercial access to the GMP-grade cell selection and activation product will be ready by the middle of 2027.
The upgrade will expand Bracco’s internal manufacturing capabilities for its streptavidin-conjugated lipid-based microbubble platform. Today, most cell therapy workflows rely on 40-year-old magnetic bead technologies for cell enrichment, a key manufacturing process. That traditional approach requires multiple time-consuming steps that can introduce regulatory and quality challenges. Bracco's innovative microbubbles can both separate and activate specific cell subtypes in a single step, streamlining manufacturing for a variety of cell therapy modalities that have struggled toward commercial scalability.
The facility modernisation includes installation of automated compounding equipment, new purification systems, and an open Restricted Access Barrier System (RABS) to enhance product protection during aseptic operations. The revamp will enable larger batch production of the streptavidin-conjugated microbubbles and improve process monitoring and manufacturing control. All process development and engineering activities are being performed internally through close collaboration among Bracco’s manufacturing, quality control, safety and biology, and quality assurance teams.
"This additional investment in our Geneva facility marks an important milestone in our mission to provide best-in-class cell selection and activation solutions to the cell and gene therapy industry," said Sophie He, Bracco’s vice president, Cell Therapy. "By modernising our GMP manufacturing capabilities, we are not only increasing our capacity to serve a rapidly growing market but also ensuring that our partners and customers can rely on the consistent quality, scalability, and regulatory compliance that advanced therapies demand."
“Our teams have already demonstrated strong technical expertise with this platform,” said Thierry Bettinger, director of Bracco Research Center Geneva. "These upgrades allow us to scale production while maintaining rigorous quality standards as we prepare for GMP-compliant manufacturing."
Bracco’s Geneva-based R&D facility has maintained GMP certification from Swissmedic, the Swiss health authority, for nearly three decades. The newly announced upgrades are designed to align the site with evolving GMP expectations while supporting ongoing nonclinical studies and preparing the company for scaled production of ancillary materials used in advanced cell therapy workflows.