How can we ensure consistency in decentralised cell therapy manufacturing?

Decentralised manufacturing could expand global access to medicines and shorten turnaround times, making it particularly valuable for therapies with short shelf lives. However, it also presents challenges around consistency, traceability and good manufacturing practice (GMP) compliance.

In this interview, Charlotte Serra, President of RAPS Switzerland Chapter, explores the importance of building consistency into decentralised cell therapy manufacturing and the challenges associated with overseeing global quality across manufacturing facilities while balancing standardisation and flexibility. She also discusses the complexities of navigating global compliance throughout evolving regulatory landscapes and in line with Annex 1.

1. What are the key quality challenges associated with decentralised cell therapy manufacturing, and how can consistency be built into the manufacturing model from the outset?

The key challenge is producing the same product across multiple, non-identical sites while maintaining patient safety and consistent quality. Hospitals and contract development and manufacturing organisations (CDMOs) often vary in facilities, systems and local practices. To address this, standardising critical design elements – such as equipment, materials, methods, training, digital workflows and quality processes – should be standardised and supported by central quality oversight.

However, standardisation alone is not enough. Consistency must also extend to decision making, information flow and escalation pathways, with clear quality ownership across the network. This ensures the same decisions are made for the same deviations, regardless of site.

2. How can manufacturers balance standardisation with the flexibility needed to operate across different manufacturing sites?

The key is recognising that consistency does not require complete uniformity. Product quality standards, critical process parameters, patient safety objectives and decision-making frameworks should remain consistent across the network, while implementation can vary between sites.

Given differences in facilities, systems and local practices, trying to make every site identical can add unnecessary complexity and limit scalability. Instead, manufacturers should use site-specific risk assessments to determine where local adaptation is acceptable, supported by central quality oversight. In simple terms: standardise what matters most and adapt locally based on risk.

3. What are the biggest challenges in maintaining global quality oversight across a decentralised manufacturing network?

Visibility is one of the biggest challenges. As networks expand, quality teams must assess issues at individual sites while also determining whether deviations, OOS results, compliance concerns or emerging trends could affect the wider network. This requires more than a central quality management system. Effective oversight relies on rapid information sharing, clear decision making and defined escalation pathways across all sites.

As the network evolved, we established connected governance structures, including a control tower for operational coordination, a product quality review board for batch-level quality governance, and a quality council for significant patient safety and compliance risks. We also moved from regional quality teams to a global quality organisation, enabling expertise and lessons learnt to be shared across the network.

4. How should manufacturers approach Annex 1 requirements when developing a decentralised cell therapy-manufacturing model?

Annex 1 should be treated as a risk-based sterility assurance framework, not as a checklist. This is particularly important for cell therapies, which cannot be terminally sterilised, making contamination prevention critical to product quality and patient safety.

Manufacturers should apply core Annex 1 principles consistently across the network, including Quality Risk Management, a Contamination Control Strategy, environmental monitoring, personnel practices, closed systems and cleanroom qualification. Implementation should then be tailored to each CDMO or hospital through site-specific risk assessments, with any mitigations subject to central quality oversight. The goal is consistent application of Annex 1 principles and equivalent risk control across the network, rather than identical facilities at every site.

5. As regulatory expectations evolve across different regions, how can companies develop a quality strategy that supports global compliance while reducing complexity?

Creating separate quality processes for each region increases complexity and can undermine consistency. A more effective approach is to build one global quality framework based on shared regulatory expectations, while managing local requirements through defined adaptations.

While regulations continue to evolve, regulators consistently prioritise strong controls, GMP compliance, sponsor oversight, chain of identity and custody, and science- and risk-based decision making. The goal should be one global standard, central governance and accountability, and local adaptation only where required. Ultimately: standardise what matters, govern centrally and adapt locally based on risk.