*Guest Article by Laura Murray, Head of Business Development, Cellular and Molecular Therapies, NHS Blood and Transplant (NHSBT). If you would like to submit an article or blog post please email [email protected].

Cell and gene therapies have moved beyond scientific promise to clinical reality. Patients with cancer, rare diseases and inherited disorders are now receiving treatments that would have seemed unimaginable just a decade ago. Yet alongside these advances sits a persistent challenge: many therapies are just too costly to deliver,

Good Manufacturing Practice (GMP) is often blamed when therapies struggle to move from R&D into clinical manufacturing and it’s easy to see why. GMP manufacturing is expensive.  However, it’s expensive for good reasons. Every reagent, consumable and material must be qualified, risk assessed and appropriately controlled for products intended for human use. Facilities require round-the-clock environmental monitoring and maintenance regardless of whether a manufacturing run lasts one day or twenty. Process validation, analytical validation and operator training require multiple end-to-end qualification runs before a therapy ever reaches a patient. Quality control, release testing and regulatory compliance add further layers of specialist expertise and cost.

Viewed this way, GMP is not expensive because of the label; it is expensive because of everything required to deliver a safe product for patients.

However, these costs are not the only affordability challenge.  In my experience, one of the greatest hidden costs in cell and gene therapy manufacturing is variability.

Unlike traditional pharmaceutical products, advanced therapies begin with biological starting materials that are inherently variable. That variability follows the product throughout technology transfer and into manufacture but the consequences extend far beyond the laboratory. Manufacturing schedules become harder to predict, deviations trigger lengthy investigations, timelines extend and batches can fail altogether.

This is why manufacturing partnerships are becoming increasingly strategic. If variability is one of the biggest drivers of cost, then manufacturing is no longer just about producing a product; it also becomes about managing uncertainty. The most valuable manufacturing partners are those that can help developers anticipate, reduce and respond to the unexpected and build flexibility into the manufacturing journey.

The partnerships on offer are beginning to reflect this reality. The traditional "build or buy" decision has given way to a spectrum of options, from commercial Contract Manufacturer to hybrid GMP facilities and public-private partnerships, allowing organisations to make more deliberate trade-offs between speed, control, cost and long-term value.

For early-stage developers, the challenges in translation and manufacturing sit alongside clinical considerations and programme uncertainty. NHS-integrated manufacturing services bring these perspectives together, combining deep GMP expertise with direct access to clinical teams and patient pathways.  In early clinical studies, when processes are still evolving and unexpected challenges are almost certain, being able to draw on that wider ecosystem can make a significant difference.  As therapies mature and commercial priorities evolve, the optimal model may change, but early decisions can have a lasting impact on cost, timelines and patient access.

There is no universally correct approach. The best manufacturing partnership will depend on the technology, stage of development, funding position and commercial ambitions of the organisation.

What matters is choosing a partner who can contribute more than manufacturing capacity; one that brings the expertise, flexibility and transparency needed to navigate inevitable challenges and keep therapies moving towards patients.