Production and purification of recombinant arylsulfatase A

US9957489B2 · kind B2 · utility

Assignee

• Shire Pharmaceuticals Ireland Limited · IE

Inventors

• Jens Fogh · Aarhus, DK
• Claes Andersson · Bissenkamp, SE
• Cecilia Weigelt · Stockholm, SE
• Christer Moller · Tullinge, SE
• Pia Hydén · Stocksund, SE

Key dates

• Filing date: Aug 2, 2013
• Grant date: May 1, 2018
• Expiry date: Jul 24, 2034

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K38/00
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The present invention pertains to a process for production of recombinant arylsulfatase A in a cell culture system, the process comprising culturing a mammalian cell capable of producing rASA in liquid medium in a system comprising one or more bio-reactors; and concentrating, purifying and formulating the rASA by a purification process comprising one or more steps of chromatography. Other aspects of the invention provides a pharmaceutical composition comprising rASA, which is efficiently endocytosed via the mannose-6-phosphate receptor pathway in vivo as well as a rhASA a medicament and use of a rhASA for the manufacture of a medicament for reducing the galactosyl sulphatide levels within target cells in the peripheral nervous system and/or within the central nervous system in a subject. A final aspect of the invention provides a method of treating a subject in need thereof, said method comprising administering to said subject a pharmaceutical composition comprising a rhASA and thereby obtaining a reduction in the galactosyl sulphatide levels in target cells within said subject.