NIBSC hosts the UK’s National Control Laboratory for biological medicines. We provide independent scientific assessment of certain biological medicines, including vaccines and products made from human blood that are licensed in the UK, to support public health.
NIBSC’s control testing provides an independent check, following marketing authorisation by the MHRA, that batches of these medicines continue to meet the required standards for quality, safety and performance before they are supplied to patients. This is particularly important for biological medicines because their inherent nature and manufacturing processes can result in variation between batches.
As the UK’s National Control Laboratory, NIBSC independently assesses batches of certain biological medicines as part of the regulatory process. This role is carried out independently of manufacturers and under UK medicines legislation. For products within scope, every batch must be independently tested and certified by us before it can be released onto the UK market.
The medicines we assess include vaccines and medicines made from human blood or plasma, such as immunoglobulins and blood coagulation factors. These include vaccines for people of all ages and for a range of purposes, from routine childhood and adult immunisations to COVID-19 and travel vaccines. We also test plasma pools, the starting material used to manufacture many plasma-derived medicines.
Our assessment can include independent laboratory testing of samples from a batch and review of the manufacturer’s batch testing and production information. We check selected characteristics of the product against its approved specifications and, when the requirements are met, certify the batch. This process provides additional independent assurance of the quality and consistency of batches supplied to patients.
Not all products or batches require the same level of NIBSC Control Testing oversight. We use a science- and risk-based approach to determine the appropriate level of assessment. Every batch undergoes independent laboratory testing, with the extent of NIBSC assessment determined according to risk.
Our approach takes account of factors such as the type and complexity of the product, its manufacturing and testing history, experience with the product and manufacturer, and any changes or emerging issues that could affect quality. The level of independent laboratory testing carried out by NIBSC can therefore change as knowledge and experience of a product develop.
Depending on the product and the regulatory arrangements that apply, NIBSC may carry out independent laboratory testing and certification, or take account of testing and certification performed by another recognised National Control Laboratory. This proportionate approach maintains appropriate independent regulatory oversight while focusing NIBSC testing where it provides the greatest additional assurance.
For manufacturers who need information about submitting batches for certification, see guidance for manufacturers.
Our control testing is delivered by scientists with expertise across a wide range of analytical methods and biological products, including:
Control Testing scientists work alongside NIBSC’s wider programmes in biological standards, reference materials and applied research. This combination of regulatory and scientific expertise helps us adapt our approaches as biological medicines and the technologies used to manufacture and test them evolve.
Biological medicines are manufactured and supplied through global networks, so collaboration between national control laboratories is an important part of effective regulatory oversight.
NIBSC has a long history of international scientific collaboration and maintains close links with regulatory authorities and laboratory networks around the world. We participate in international networks for the control and standardisation of biological medicines and work with other national control laboratories to support consistent scientific approaches to independent testing and certification.
We are a member of the General European Official Medicines Control Laboratory Network (GEON), an observer within the Official Control Authority Batch Release (OCABR) network, and a member of the World Health Organization Network of National Biological Standardisation Laboratories.
We also perform testing to support the WHO Vaccine Prequalification Programme and offer contract testing services to manufacturers and other organisations.
Information on Control Testing performance, including published performance metrics, is available on GOV.UK.
For enquiries about Control Testing of biological medicines contact ControlTesting@mhra.gov.uk.