Cell therapy

For more than 20 years, NHSBT has supported academic institutions, biotechnology companies and clinical investigators in translating innovative cell therapies into GMP-manufactured investigational medicinal products for clinical trials.

With 3 MHRA-licensed Advanced Therapy Units, experienced multidisciplinary teams and access to NHSBT’s unique healthcare infrastructure, we provide flexible manufacturing solutions that help de-risk development and accelerate clinical programmes.

Why work with NHS Blood and Transplant?

Our approach to cell therapy projects

We support programmes from initial process assessment through to GMP manufacture and clinical supply.

Process assessment and gap analysis

Every project begins with a detailed review of your product and manufacturing process.

Working closely with your team, we assess the requirements for GMP translation, evaluating factors such as:

• manufacturing methodology
• product specifications
• quality control and potency testing
• culture conditions
• fill and finish requirements
• regulatory expectations
• overall clinical manufacturing strategy

This early assessment helps identify potential challenges and define the most efficient route to clinical manufacture.

Technology transfer

Successful technology transfer is critical to ensuring a robust and reproducible manufacturing process.

Our experienced teams work alongside clients to capture process knowledge and establish effective transfer plans.

Through a combination of training, process familiarisation activities and small-scale development runs, we help ensure that critical product characteristics are maintained while generating valuable data to support comparability studies and future regulatory submissions.

Process development and GMP optimisation

Once a process has been transferred, our scientists adapt and optimise it for implementation within a GMP environment.

This stage focuses on refining manufacturing workflows, integrating processes into cleanroom operations and developing appropriate quality control strategies.

We work collaboratively with clients to establish product specifications and develop or validate analytical methods, ensuring the process is both compliant and scalable while preserving the integrity of the final product.

GMP validation

Validation activities generate the evidence required to demonstrate that a manufacturing process is consistent, robust and suitable for clinical production.

The resulting data and documentation support key regulatory milestones, including Investigational Medicinal Product Dossier (IMPD) submissions, Clinical Trial Applications (CTAs), funding applications and regulatory inspections.

GMP manufacturing and product release

Following successful validation, we manufacture clinical trial batches according to agreed production schedules within our MHRA-licensed GMP facilities.

Supported by comprehensive quality oversight, quality control testing and batch review processes, products are released for clinical use with full regulatory compliance and traceability.

Specialist expertise in mesenchymal stromal cell therapies

NHSBT has established one of the UK's leading GMP manufacturing capabilities for umbilical cord tissue derived and bone marrow derived mesenchymal stromal cell (MSC) therapies.

Our validated MSC platform combines specialist manufacturing expertise with access to high-quality starting material sourced through NHSBT's national donation programmes.

Our MSC platform includes:

• GMP-grade umbilical cord tissue sourced through NHSBT donation networks
• validated manufacturing process for cord-derived MSCs
• automated closed-system manufacturing using the Terumo Quantum™ bioreactor
• comprehensive donor screening and product testing
• GMP quality oversight throughout manufacture
• cryopreservation and long-term vapour-phase liquid nitrogen storage

The result is a scalable, reproducible manufacturing process capable of supporting both early and later-stage clinical development.

Supporting innovative clinical programmes

Our manufacturing teams have supported numerous pioneering cell therapy programmes across multiple therapeutic indications.

Examples include:

• REALIST: Acute Respiratory Distress Syndrome (ARDS), including COVID-19 ARDS
• MERLIN: Primary Sclerosing Cholangitis and Autoimmune Hepatitis
• NEPHSTROM: Diabetic Kidney Disease
• AUTUMN: Regulatory T-cell therapy for autoimmune liver disease
• AMELIE: Muscle cell therapy for faecal incontinence
• Cell Bandage: MSC collagen bandage for meniscal repair
• RESTORE: Stem cell-derived red blood cells
• CAR-T manufacture for blood cancer

Our experience across these programmes provides practical insight into the challenges of translating novel cell therapies into successful clinical manufacturing programmes.