In addition to offering independent Official Control Authority Batch Release Certificate testing of batches of biological medicines, NIBSC performs contract testing services.

We can use our specialist expertise in the characterisation and standardisation of biological medicines to carry out a range of projects.  Examples include:

• proof of concept testing of early stage biological medicines 

• testing to help companies validate their in-house assays or reference materials

• final product testing for those biological medicines that are not used in Europe

However, our Statutory Role means that we must decline some product testing work.  In addition to being the UK’s Official Medicines Control Laboratory (OMCL) for biological medicines, many of our scientists are members of various committees and give advice on biological medicines.

NIBSC therefore is conscious of the potential for conflicts of interest when it carries out contract testing work for third parties.  This is especially true where the product or technology in question is one where we may be asked to carry out control testing activities or give advice in the future. 

As a result, NIBSC has a process of internal approval for all potential contract work.

We are always happy to discuss potential contract testing projects.   To find out more please contact us

For further information on our areas of scientific expertise, please follow this link