GMP Manufacturing

Clinical Manufacturing

Effective clinical manufacturing is key to moving cell and gene therapies from development to patients. Our GMP services de-risk early-phase programmes and simplify complexity with cleanroom capacity, integrated fill-finish, and expert cross-functional support.

Accelerating Your Therapy into Clinical Trials

Seamless technology transfer is critical to successful GMP manufacture.

Manufacturing clinical trial material for cell and gene therapies requires precise coordination between process readiness, GMP compliance, and regulatory documentation. For developers transitioning into clinical trials, challenges often include facility access, small-batch flexibility, and the need to maintain consistency across multiple trial phases.

We bridge the gap between development and manufacture by offering standalone clinical manufacturing, direct technology transfer from clients, or integrated tech transfer from our in-house Process Development team. This flexible approach ensures each clinical programme is built on a solid technical and regulatory foundation.

Whether you’re working with autologous cell therapies, viral vectors, RNA-LNPs or allogeneic cell therapy platforms such as iPSC or MSCs, we understand the complexity of clinical timelines and design our services around the needs of your therapy.

Our Approach & Expertise

We design our clinical manufacturing programmes with flexibility, quality, and scalability at the core. Whether you’re working with a viral vector, an allogeneic cell therapy, or a patient-specific autologous product, we ensure every project is aligned to your regulatory strategy and delivered with confidence.

For viral vectors, we offer production at scales of up to 2 x 200L using batch fermentation or flask-based expansion methods. These can be manufactured either as clinical product or as starting material for cell-based gene therapies. Allogeneic therapies can also be manufactured at similar scales, and we support GMP cell banking for a range of cell types.

Autologous cell and gene therapies are manufactured on a patient-specific basis using closed processing and single-use disposable materials. These workflows are optimised for sterility assurance, traceability, and rapid turnaround across multiple individual batches.

Each programme is delivered by our integrated team from GMP production and QC scientists through to dedicated QA and Qualified Persons (QPs), supported by our process development scientists and analytical services team. This cross-functional support ensures your clinical manufacturing is built for success today and ready to scale for tomorrow.

Clinical Manufacturing Capabilities

Seamless Technology Transfer

Support for direct tech transfer or integrated transition from our Process Development team, ensuring minimal risk and maximum continuity.

GMP Clinical Manufacture

Production of clinical-grade material for Phase I–III trials, including full GMP documentation and QP certification.

Cleanroom Infrastructure

Four Grade C cleanroom modules supporting upstream, downstream, formulation and aseptic fill-finish activities across a range of modalities.

GMP Support Services

On-site warehouse and QC functions provide compliant storage, sample management, and testing coordination to support seamless GMP clinical manufacturing and batch release.

Flexible Batch Configurations

Capability to deliver single batches, multi-batch campaigns, or patient-specific batches for autologous programmes.

Integrated Fill-Finish

On-site isolator technology enables clinical vial or bag filling as part of a manufacturing run or as a standalone service.

End-to-End Traceability

Full GMP records, documentation and audit trails maintained to support regulatory submissions and ensure batch integrity.

Optimise and Scale Your Clinical Programme with Confidence

From tech transfer to GMP batch production, we deliver end-to-end support for your clinical manufacturing needs. Contact us today to discuss your clinical requirements.

Request a Proposal

Other GMP Manufacturing Services

Cell Banking

We offer GMP-compliant cell bank production as a standalone service or as part of a wider manufacturing programme. With experience in banking iPSCs, MSCs, and HEK293s, our services include 2D/3D expansion, validated cryopreservation, secure storage, and full QC testing and documentation.

Commercial Manufacturing

With future-ready capacity and scalable GMP solutions, our commercial manufacturing services support clients moving into late-stage and commercial production. Our 12,000ft² (1,100m²) expansion space is designed to accommodate larger batch production, supporting 500–1000L viral vector processes, RNA, Lipid Nanoparticles (LNPs), and other advanced technologies.

Fill Finish

Our dedicated fill finish module includes Grade C cleanroom space and a closed Grade A isolator system. We support clinical vial and bag filling for viral vectors and allogeneic therapies, offering standalone or integrated fill finish with full QA oversight and sterility assurance.

GMP Quality & Regulatory

Our in-house QPs and regulatory specialists offer proactive quality oversight and GMP support, from documentation and batch release to audit readiness and training. We ensure compliance is embedded at every stage of your manufacturing journey.

Our Facility

Designed with flexibility, scalability, and compliance in mind, our GMP facility supports the full spectrum of cell and gene therapy modalities. Featuring dedicated manufacturing suites, Fill Finish areas, and QC laboratories, the facility ensures an end-to-end manufacturing solution under one roof.