CGT manufacturing is breaking out of the cleanroom and moving closer to the patient. What does this mean for healthcare professionals, CDMOs—and biotech strategy itself? From hybrid networks to digital-first production and bedside co-manufacturing, the rules are being rewritten.
We’re standing at the edge of a manufacturing revolution in Cell and Gene Therapy (CGT). An important new chapter is starting. Leaders will emerge. Others will be left behind but progress is inevitable.
The days of one-size-fits-all, centralised production,are numbered. The next era will be defined by point-of-care (POC) and modular manufacturing (MM) models that prioritise patient proximity, digital integration, and operational flexibility.
What’s To Come:
- Localised Manufacturing at Scale: New regulatory guidance, including recent moves by the MHRA, is accelerating the need for decentralised manufacturing as a standard—bringing therapies physically and operationally closer to patients. It’s not just about geography; it’s about impact. Shorter lead times. Faster access. Smarter logistics. A radical change to the patient journey, a much more patient centric supply chain.
- Hybrid Operating Models: A blend of internal and external manufacturing capability is emerging. CDMOs, biotech firms, and healthcare providers are converging to form distributed networks that can adapt in real time to demand. The “hybrid” factory model will become the norm—closer to patients, but still underpinned by industrial-grade quality systems.
- Digital-First, Automation-Driven: From real-time QA to fully closed systems at the bedside, digital infrastructure will no longer be optional. Expect GMP-compliant platforms, robotic process automation, and connected cleanrooms to be central to operational design. Agentic AI is on the rise also, with connected agents managing tasks that are subject to automation across the value chain, from patient demand modelling, to scenario planning, to automated capacity planning and real-time in-process manufacturing data analysis.
Implications for HCPs, CDMOs and Biotechs:
- HCPs As Co-Manufacturers: As more therapies are made within or near clinical sites, healthcare professionals will increasingly share responsibility for aspects of production. This shift brings a real need for streamlined, dynamic SOPs, enhanced training, and smarter digital systems to reduce admin burden, complexity and workload. This is important HCP’s won’t be able to cope as an integral part of the manufacturing process otherwise. Start with the patient and HCP and work backwards.
- CDMOs Will Lead Locally: To remain competitive, CDMOs will need to embed themselves within these distributed networks, or even create full ecosystems from scratch. Expect a rise in partnerships, regional micro-sites, turnkey manufacturing solutions and even shared ownership structures between CDMOs and MAHs, operationally speaking. A new operational value chain is emerging.
- Biotechs Must Rethink Network Strategy: For biotech companies, this means moving from centralised to hybrid network planning—designing manufacturing ecosystems that include both internal capabilities and external partnerships. Long-term planning must now account for regulatory complexity, digital interoperability, and cross-border operational models. Those who embrace this shift early will set the pace for the rest of the industry.
Sustainable CGT Economics Considerations
As the cell and gene therapy sector evolves in terms of science, manufacturing and solution providers, it’s becoming increasingly clear that sustainability is not just an environmental concern—it’s an economic imperative.
Manufacturing cost remains one of the most significant barriers to wider patient access. Even as scientific breakthroughs continue, many therapies are still priced at levels that challenge reimbursement systems, restrict access, and strain healthcare budgets.
Decentralised and hybrid manufacturing models offer a potential path forward. By reducing supply chain complexity, lead times, and reliance on centralised infrastructure, these models could lower the per-product cost over time. But to achieve this, the industry must address several key areas:
- Process Standardisation: Modular, interoperable systems across sites can reduce variability and training costs. This matter even more if HCP’s are to take part in the manufacturing process going forward.
- Digital Efficiency: End-to-end digitalisation, from QA to batch release, will be critical to reducing operational overheads.
- Capacity Utilisation: Hybrid networks allow for smarter allocation of capacity—balancing in-house flexibility with CDMO expertise.
- Payer Confidence: Demonstrating consistency, scalability, and cost-efficiency in manufacturing will be crucial for building trust with payers and proving long-term value.
Clossing summary :
The stakes are high. So much so, that without a manufacturing model that scales sustainably, many promising therapies will remain financially out of reach—especially in rare disease areas where patient populations are small and logistics are complex.
In short: Reimagining manufacturing isn’t just about innovation—it’s about making CGT viable for real-world healthcare systems.
If we get this right, the CGT manufacturing future will be faster, safer, and more sustainable. But it will take BOLD moves: standardising across borders, automating where possible, and fostering deep collaboration between regulators, industry, and clinicians. That’s true collaboration with practical pilots and results, not the buzz-word we keep on hearing at conferences or fancy PPT slides.
This is not just evolution—it’s a chance to fully rebuild the manufacturing value chain from the patient outwards.
At Radix Partners we have the vision and hands-on industry experience to help lead network planning strategies and scale up initiatives both on the biotech and CDMO side. Please reach out to discuss further about your challenges,ambitions and long term plans.
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