In addition to offering Independent Control Testing of batches of biological medicines, the NIBSC performs a limited range of contract testing services.
We use our specialist expertise in the characterisation, standardisation and control of biological medicines to help with, for example:
- proof of concept testing of early-stage developmental biological medicines
- testing to help companies validate their in-house assays or reference materials
- development of new or improved assays for testing biological medicines
- final product testing for biological medicines that are not destined for Europe
As part of the UK medicine’s regulator, we are conscious of the potential for an actual or perceived conflict of interest between our contract testing work and the institute’s regulatory activities.
In general, with the exception of Independent Testing and data that will not be relied on when making regulatory decisions, data exculsively provided by us to one organisation cannot be included in European regulatory submissions.