The present invention relates, generally, to the fields of immunology and
molecular biology. The invention discloses, more particularly, new and
improved interleukin-7 drug substances, corresponding specific
immunoreactive antibodies, as well as compositions comprising the same,
their preparation and uses. The invention also discloses methods to
characterize the impurity profile of a r-hIL-7 drug substance used for
therapeutic purpose, as well as optimized nucleotide sequences encoding
mammalian IL-7, recombinant expression vectors and methods for preparing
and purifying said polypeptides. The present invention stems from the
unexpected discovery that the long term activity of recombinant IL-7 is
mostly expressed by a specific conformer and that other conformers,
potential product-related substances, product-related impurities, and
process-related impurities, which would normally be included in the
specification of the drug substance and/or drug product, although
bioactive, should be strictly minimized because they are able to trigger
an immune reaction against the desired IL-7 molecule.