IL-7 drug substance, composition, preparation and uses
US7585947B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Aug 6, 2003 |
| Grant date | Sep 8, 2009 |
| Priority date | — |
| Expiry date | Mar 23, 2024 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC12N2799/022
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
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.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.