Customised biological materials
As the world leader in the development and production of reference materials used to test biological medicines, NIBSC is skilled in preparing customised biological reference materials to exacting specifications for accuracy and precision of fill, oxygen content and moisture content.
Such customised materials can be particularly helpful when filling or freeze-drying a material that has specifications or characteristics which are cannot be achieved by a facility that prepares formulated medicinal products.
Why choose NIBSC to produce your customised reference materials?
NIBSC has decades of experience in developing biological reference materials for safety and potency testing of a wide range of products and for use in in vitro diagnostic assays. Our expertise and customised-filling facilities help us produce materials with optimal characteristics, including:
- accuracy and precision - our purpose-built filling unit operates to very high precision, with a coefficient of variation for the fill volume being typically less than 1%
- stability and shelf-life - we can achieve increased stability and shelf life of biological materials through our expertise in formulation and through our ability to achieve very low residual moisture levels when freeze-drying; NIBSC can also freeze-dry into ampoules to further enhance the material’s stability
- batch homogeneity – we use our expertise in filling to achieve a good homogeneity throughout the batch of material
Customised cell lines
In addition to providing customised reference materials, NIBSC’s UK Stem Cell Bank has unparalleled experience in establishing quality assured human embryonic and other cell lines. We welcome opportunities to develop further links and explore potential customisation projects.