Adapting mAb sites for Gene Therapy
Can one facility really handle both mAbs and Gene Therapy?
As biopharmaceutical innovation accelerates, a critical question emerges: can a single facility support both monoclonal antibody (mAb) production and gene therapy manufacturing?
PM Group’s Technical Director, Alf Penfold and Bayer’s Senior Director – BioPartnering, John Kenneally, recently explored this challenge, sharing insights from a feasibility study that tested the boundaries of facility flexibility and biosafety compliance. Their findings reveal a compelling case for dual-use manufacturing - one that challenges traditional assumptions and opens new possibilities for multi-modality production.
Rethinking facility design
The study focused on adapting an existing GMP mAb drug substance facility to accommodate vector-based gene therapies. The goal was to enable campaign-based manufacturing for both modalities without
extensive structural changes. The outcome demonstrated that dual use is not only feasible but can be achieved with thoughtful design and targeted upgrades.
Shared infrastructure, streamlined processes
One of the most striking insights was the overlap in equipment and process flow between mAbs and gene therapies. From cell expansion to purification, the steps align closely. The need for dedicated equipment was minimal and single-use technology played a pivotal role in simplifying transitions between products.
“This convergence of process design supports a more agile manufacturing environment.”
Navigating biosafety requirements
The most significant challenge was meeting biosafety standards. Gene therapy production requires BSL-2 containment, which the original mAb facility did not have. Upgrades included an isolator for viral vector handling and sink airlocks.
These modifications ensured safe handling of biohazardous materials, particularly when working with helper viruses. Waste management was also addressed, with validated heat treatment systems and above-ground drainage solutions introduced to meet containment standards.
Risk mitigation through design
An early-stage FMEA risk assessment identified potential cross-contamination risks. These were mitigated through engineering and procedural controls. The use of single-use components minimised the need for cleaning validation and reduced the risk of product carryover.
Temporal segregation strategies were introduced to manage personnel and waste flow, especially in shared corridors. These measures helped maintain biosafety integrity without compromising operational efficiency.
Regulatory confidence
To validate the approach, the team engaged with the FDA in a Type B meeting. The agency found the plan to “appear acceptable”, noting the layout, containment features and single-use systems. One recommendation by the FDA was the introduction of VHP decontamination of the helper virus isolator.
This feedback reinforced the robustness of the design and confirmed that the facility could meet regulatory expectations for both mAbs and gene therapies.
A new model for multi-modality manufacturing
The findings present a compelling model for accommodating multiple modalities within a single facility. With strategic planning, shared infrastructure and targeted upgrades, complex biologics can be manufactured side by side.
“This approach challenges the notion that specialised facilities are the only path forward. It offers a blueprint for scalable, flexible production environments that can evolve with the science.”
Alf Penfold
Technical Director - GMP/Regulatory Compliance
This model of dual-use manufacturing reflects a shift in how biologics facilities can be designed and operated.
