What are customised reference materials?

Where no appropriate reference material exists for a particular product, NIBSC can develop a customised standard, tailored for a particular biological medicine or in vitro diagnostic test.  This is particularly relevant for pegylated recombinant products and biosimilars/generic medicines that have come off patent.

The three key indicators of biological reference material’s quality are the accuracy of the fill volume, the material’s stability and its homogeneity throughout the batch. NIBSC’s purpose-built filling unit operates to very tight variability, typically less than 1%.  The Institute’s expertise in formulation helps to ensure batch homogeneity and stability.  The filling facilities at NIBSC mean that the Institute is able to offer contract fill facilities.  NIBSC can fill and freeze-dry into a range of ampoules, vials and tubes for both non-infectious materials and materials of up to level 3 microbiological containment.

NIBSC freeze-dry development scientists can develop a freeze-dry formulation and process for individual biological products.  Freeze-drying at NIBSC can be carried out at very low residual moisture levels and this can increase the material's shelf-life and stability.  Once filled, extensive analytical services are available to monitor the quality of the final material.

 

Why choose NIBSC to produce your customised reference materials?

NIBSC is a world leading centre of excellence for biological standardisation.  Its scientists have decades of experience in the development of new bioassays and the reference materials used to standardise them.

 

Users of NIBSC’s customised reference materials service benefit from:

 

• our development expertise:

  • in bioassays and reference materials

  • in formulation and freeze-dry process 

• high degree of reproducibility due to: 

  • high accuracy of fill volume

  • batch homogeneity

• choice of presentation:

  • liquid fill or freeze-dry

  • choice of ampoules, vials or tubes

 

NIBSC has decades of experience in developing biological reference materials for safety and potency testing of a wide range of biological medicines, and for use in in vitro diagnostic assays.  We are always happy to discuss potential customisation projects.  

 

To find out more please contact us.

 

Our range of catalogue reference materials can be found here.