Quality control testing
Analytical testing of starting materials through to final products
We offer a complete range of analytical testing services for cellular and molecular therapies, from starting materials all the way through to final products.
Our in-process testing ensures that manufacturing is consistent, and products are safe and effective, in line with regulatory guidelines.
Why work with NHS Blood and Transplant?
20+ years of experience
With more than two decades of experience testing cell and gene therapies, and 6 Human Tissue Authority (HTA) or Medicines and Healthcare products Regulatory Agency (MHRA) licensed facilities across the UK, we have the knowledge and experience to determine the safety, identity, purity and potency of your products.
We understand the complex and evolving nature of advanced therapeutic medicinal products (ATMPs), and our quality control (QC) team can use their experience to determine the testing requirements of your product. This can include starting material, in-process material, final release and stability testing.
Regulatory compliance
We have held a Manufacturing and Import Authorisation for investigational medicinal products (IMPs) from the MHRA since 2004.
All good manufacturing practice (GMP) assays we perform are validated and maintained in accordance with our robust quality management system.
Comprehensive testing capabilities
Our testing capabilities span a range of products, including molecular, cellular and viral vector products, and can be provided as part of an end-to-end process.
We can also provide guidance on the tests that need to be carried out according to your product.
Assays
We offer an extensive range of in-house analytical assays, and can develop, optimise and validate assays that are specific to your product. We are also comfortable with the transfer of your technology.
Whether your assay is fully GMP compliant, or only performed in a research capacity, one of our dedicated assay development and method validation scientists can work with you to optimise and validate it for use in our laboratories.
Assays by product type
The following are example assays. Please contact us about any specific requirements for your product.
Stability trials
We offer fully bespoke stability trials depending on the requirements of your product.
We can help design the stability protocol, including the length of the trial, storage conditions, and tests and specifications required at each point in time. We can also run accelerated stability trials.
Your product will be stored in accordance with its requirements at one of our licensed sites for the duration of the trial.