
The section has been actively involved in the standardisation
and control of Cytokines and Growth Factors since 1980. Over
90% of the WHO international standards and reference reagents for
these biologically active proteins, e.g., IFN-β, G-CSF have been
produced here. Development of standards and reference reagents for
novel cytokines and growth factors with therapeutic potential are
continually pursued. Other activities include quality testing of
products as an OMCL for the EU co-ordinated centrally authorised
product testing scheme (and contractual purposes), development and
implementation of new assays for evaluation of products in
development e.g., second-generation, biosimilar products, and for
investigations relating to assessment of unwanted immunogenicity of
a range of biotherapeutics including cytokines, monoclonal
antibodies and fusion proteins. The section contributes to the
EMEA/Biosimilar Medicines Working Party and collaborates with
manufacturers in the evaluation of new therapeutics under
development.