Fill and finish
Fully GMP-compliant aseptic fill and finish service
We offer a good manufacturing practice (GMP) compliant aseptic fill and finish service.
With more than 2 decades of experience as a trusted GMP manufacturing partner, we provide reliable, high-quality support for advanced therapeutic medicinal products (ATMPs).
Our fill and finish capability forms a key part of our end‑to‑end service offering. It's backed by a robust quality management system, ensuring consistency, regulatory alignment, and complete traceability throughout the manufacturing workflow.
Why work with NHS Blood and Transplant?
More than 20 years of ATMP experience
We have experience in the aseptic filling and finish of a wide range of ATMP formats in multiple final container formats, including:
- plasmids
- viral vectors
- cell therapy products
- mammalian cell banks
- microbial cell banks
Experience in release for clinical trials
We hold full Medicines and Healthcare products Regulatory Agency (MHRA) GMP certification and have extensive experience in regulatory audits and product release.
Our work is underpinned by robust documentation and quality management systems.
End-to-end or standalone support
Our fill and finish service can be provided as part of our full service offering for ATMP production, or as a standalone addition to your own manufacturing process.
How we work
We deliver high quality, GMP-compliant fill and finish services.
Aseptic filling environment
Products can be processed using a grade A positive‑pressure isolator within a grade C cleanroom, ensuring sterility throughout.
Filling systems
We support a range of product types and formats. For vial filling, we use:
- a closed vial filling system
- laser‑sealing technology
- disposable needle assemblies to maintain sterility
Quality management system
We have extensive experience in quality management, in close alignment with Medicines and Healthcare products Regulatory Agency (MHRA) regulation.
Qualified person release
Qualified persons (QPs) have legal responsibility for certifying pharmaceutical products before use, ensuring compliance and quality of investigative medicinal products (IMPs).
Capabilities
Our aseptic filling technology provides:
- up to 500 bottles per batch
- fill volumes from <1 mL to 50 mL
- comprehensive quality control testing
- cold storage and cryopreservation facilities
- fill and release for clinical trials
- labelling or import and relabelling
- QP release