Shire Pharmaceuticals Ireland Limited

Chiesi Farmaceutici S.p.a.

Zymenex A/s

Pia Hydén

Jens Fogh

Claes Andersson

Cecilia Weigelt

Stefan Nilsson

Helena Reuterwall

Christer Moller

Kerstin Lundell

Magnus Hjertman

Pia Ringholm Gulstad

Christer Môller

Christer MØLLER

The present invention relates to a process for purification of recombinant alpha-mannosidase, a process for production of alpha-mannosidase, a composition comprising alpha-mannosidase, use of the composition as a medicament, use as a medicament for the treatment of alpha-mannosidosis and a method of treating alpha-mannosidosis and/or alleviating the symptoms of alpha-mannosidosis.

Process for production and purification of recombinant lysosomal alpha-mannosidase

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.

Production and purification of recombinant arylsulfatase A

Production and purification of recombinant arylsulftase

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Stocksund, Sweden

Pia Hydén