NIBSC - Contract testing

Contract testing

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.

Find out about our customised services

Our scientists are happy to discuss potential customisation projects. To help us direct your enquiry to the relevant scientist please let us know your area of interest.

Please send your requests to business@nibsc.org, including the following information:

- name
- organisation
- email address
- telephone
- material(s) to be tested
- test to be carried out (if known)
- is the material an actual or developmental biological medicine?
- use to which NIBSC’s results will be put