Novozymes Biopharma Dk A/s

Albumedix A/s

David John Mead

Darrell Sleep

David James Ballance

Hendrik Van Urk

Philip Harvey Morton

Andrew John Cartwright

Jason Cameron

John Rodney Woodrow

Stephen Berezenko

Jean-Luc Bernard Veron

Michel Gaston Joseph Grandgeorge

A process is provided for the preparation of a highly pure albumin solution the process comprising subjecting albumin (preferably expressed and secreted by transformed yeast) to a series of chromatographic steps. Preferably, the process comprises the steps of positive mode cation exchange chromatography, positive mode anion exchange chromatography, positive mode affinity chromatography, negative mode affinity chromatography (preferably using immobilized aminophenylboronic acid), negative mode cation exchange chromatography, and negative or positive mode anion exchange chromatography. A process for reducing the level of nickel in an albumin solution is also disclosed, as is a recombinant albumin coding sequence comprising two or more in-frame translation stop codons. Also disclosed is a process for producing recombinant albumin, the process comprising culturing a fungal cell expressing a recombinant albumin coding sequence, wherein the cell has a reduced capacity of mannosylation of the recombinantly-expressed albumin.

Process for the purification of recombinant albumin

A process is provided for the preparation of a highly pure recombinant albumin solution having a nickel ion content of less than 100 ng per gram of albumin. The process comprises subjecting a recombinant albumin to a series of chromatography, concentration, and diafiltration steps.

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Nottingham, United Kingdom

David John Mead