Supported Guy’s and St Thomas’ NHS Foundation Trust with long-term QP leadership, helping establish and sustain GMP cell therapy manufacturing capabilities that enabled academic programmes to progress into clinical development and patient treatment.
Case Studies
Supporting 15 Years of GMP Cell Therapy Manufacturing Through QP Leadership
The Challenge: Creating a Sustainable Framework for Clinical Translation
Translating academic cell therapy research into clinical development requires more than scientific expertise. It demands robust GMP manufacturing capabilities, experienced quality leadership, and a regulatory framework capable of supporting increasingly complex Advanced Therapy Medicinal Product (ATMP) programmes. Guy’s and St Thomas’ NHS Foundation Trust sought to establish and maintain a GMP-compliant cell therapy manufacturing capability that could support the development and delivery of innovative therapies while meeting evolving regulatory expectations. The challenge was not simply achieving compliance. It was creating a sustainable quality and governance framework that could support clinical translation over the long term.
Our Approach
eXmoor Pharma provided embedded Qualified Person (QP) support to the Guy’s Cell Therapy Facility for more than 15 years, acting as a long-term partner throughout the facility’s evolution. Our involvement extended beyond routine batch certification. Working alongside facility leadership, manufacturing teams and quality personnel, we supported the development of quality systems, regulatory strategy, operational governance and GMP compliance processes that enabled the facility to grow and adapt as new programmes were introduced. This included support with facility licensing activities, implementation of the Pharmaceutical Quality System (PQS), establishment of GMP governance processes, recruitment and training of personnel, and ongoing quality oversight.
Deliverables
The Outcome
Impact
Over more than 15 years, eXmoor Pharma helped establish and sustain a GMP manufacturing capability that supported the translation of academic cell therapy research into clinical development.
The facility has supported 14 ATMP clinical trials and approximately 170 patient treatments, providing the quality systems, regulatory oversight and QP leadership needed to move promising therapies from research towards patients.
Several programmes supported through the facility have gone on to shape the wider UK cell therapy ecosystem, including contributing to the formation of companies such as Quell Therapeutics and Leucid Bio. Today, eXmoor Pharma continues its relationship with Quell Therapeutics as its GMP manufacturing partner, demonstrating the long-term value of partnerships built through clinical translation.
“eXmoor Pharma has provided consistent QP leadership and practical quality support throughout the development of our cell therapy manufacturing capability. Their team has worked closely with us over many years, helping us navigate evolving GMP requirements and support the progression of academic cell therapy programmes into clinical development.”
Case Studies
See how eXmoor Pharma has helped biotech innovators scale their therapies with precision and efficiency.
Strengthening Quality Operations for an Allogeneic T-Cell Therapy Developer
Helped a clinical-stage allogeneic gamma-delta T-cell therapy developer regain control of quality operations and supplier oversight following organisational restructuring, without compromising compliance or product quality.
Translating iPSC Processes for Scalable GMP Manufacturing
Successfully converted adherent iPSC cultures to scalable suspension systems, enabling GMP-compliant clinical manufacturing and commercial scale-up readiness.
Let’s Accelerate Your Therapy Together
Whether you’re in early-stage development or scaling up for commercial production, eXmoor Pharma provides the expertise and flexibility you need. Partner with us to move your therapy forward with confidence.