Manufacture of degarelix

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 dissolut...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: Mörnstam, Birgitta, Gottschalk Bøving, Tine Elisabeth, Nilsson, Anders, Rasmussen, Jon Holbech, Fomsgaard, Jens, Tsirk, Anders, Annby, Ulf, Schwach, Grégoire
Format: Patent
Sprache:eng
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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, a and processes for providing this lyophilized degarelix drug substance.