EP4512389
MANUFACTURE OF DEGARELIX
Zusammenfassung
The present invention provides methods for producing a lyophilized degarelix product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas.The present invention also provides a lyophilized degarelix drug substance which shows, upon dissolution in water in an amount of 20 mg/ml, a viscosity of up to 3.2 mPas, and processes for providing this lyophilized degarelix drug substance.
Anmelder
FERRING BV [NL]Ferring B.V.
Erfinder
SCHWACH GRÉGOIRE [DK]NILSSON ANDERS [SE]GOTTSCHALK BOEVING TINE ELISABETH [DK]RASMUSSEN JON HOLBECH [DK]MÖRNSTAM BIRGITTA [SE]TSIRK ANDERS [SE]ANNBY ULF [SE]FOMSGAARD JENS [DK]SCHWACH, GrégoireNILSSON, AndersGOTTSCHALK BOEVING, Tine ElisabethRASMUSSEN, Jon HolbechMÖRNSTAM, BirgittaTSIRK, AndersANNBY, UlfFOMSGAARD, Jens
Externe Quellen
Klassifikation
IPC-Klassen
A61K 9/00A61K 38/09A61K 47/12A61K 9/19
CPC-Klassen
A61K 38/08A61K 38/09A61K 38/25A61K 47/12A61K 47/26A61K 9/0019A61K 9/0024A61K 9/1623A61K 9/19A61P 35/00C07K 7/06C07K 7/23
AI: Life SciencesBiopharma