The updated EU GMP Annex 1 guidance has introduced stricter expectations around the separation of operators and products during aseptic filling operations.
For Bracco, these evolving requirements became a key driver in plans to prepare its pilot plant facility for the manufacture of its new BubbleGen product line, designed to improve cell separation and activation for advanced therapies.
At the heart of Annex 1 is a stronger emphasis on contamination control by design.
Manufacturers are now expected to implement systems that minimise contamination risk through engineered solutions rather than relying solely on procedural controls.
Historically, Bracco’s aseptic manufacturing processes relied on optimised personnel and material flows, rigorous aseptic techniques, strict operator gowning, validated biodecontamination programmes, and comprehensive environmental monitoring and aseptic process simulations.
Supported by a robust Contamination Control Strategy and extensive quality oversight, this approach ensured product sterility despite the absence of physical barrier technologies across the entire production line.
These measures were validated over decades of operation, with regulators, including Swissmedic, continuing to certify the company’s pilot facility in Geneva for more than 25 consecutive years.
While the facility has demonstrated long-term regulatory robustness, the company recognised that maintaining compliance without additional barrier technologies would increasingly depend on extensive regulatory discussions.
Rather than taking a reactive approach, Bracco chose to align with Annex 1 expectations ahead of increasing regulatory pressure.
The move is intended to support readiness for GMP BubbleGen manufacturing from 2027 while establishing a compliant foundation for future products.
Beyond compliance, the company also viewed the installation of an open RABS as an opportunity to strengthen product protection, improve process robustness and future-proof manufacturing operations.
Evaluating manufacturing options: alternatives to RABS
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