Purified rhIGF-I/rhIGFBP-3 complexes and their method of manufacture
View Patent ↗Complexes of IGF-I and IGFBP-3 with new levels of purity are provided. Chromatographic techniques have been developed that remove contaminants, such as mass and charge variants of IGFBP-3. The new techniques enable the production of high-quality pharmaceutical compositions comprising IGF-I/IGFBP-3 complexes.
1. An isolated protein complex comprising insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3), wherein said protein complex is at least 96% free of mass and charge variants as measured by analytical CM-HPLC.
2. The protein complex of claim 1 , wherein said protein complex is at least 97% free of mass and charge variant as measured by analytical CM-HPLC.
3. The protein complex of claim 1 , wherein said protein complex is at least 98% free of mass and charge variants as measured by analytical CM-HPLC.
4. The protein complex of claim 1 , wherein said protein complex is at least 99% free of mass and charge variants as measured by analytical CM-HPLC.
5. The protein complex of claim 1 , wherein said protein complex comprises IGF-I and IGFBP-3 in a molar ratio from about 0.8:1 to about 1.2:1.
6. The protein complex of claim 1 , wherein said protein complex comprises IGF-I and IGFBP-3 in a molar ratio of about 1:1.
7. A pharmaceutical composition comprising an isolated protein complex comprising insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3) and a pharmaceutically acceptable carrier, wherein said protein complex is at least 96% free of mass and charge variants as measured by analytical CM-HPLC.
8. The pharmaceutical composition of claim 7 , wherein said protein complex is at least 97% free of mass and charge variants as measured by analytical CM-HPLC.
9. The pharmaceutical composition of claim 7 , wherein said protein complex is at least 98% free of mass and charge variants as measured by analytical CM-HPLC.
10. The pharmaceutical composition of claim 7 , wherein said protein complex is at least 99% free of mass and charge variants as measured by analytical CM-HPLC.