Delta Biotechnology Limited

Novozymes Biopharma Dk A/s

Novozymes Biopharma UK Limited

Novozymes Delta, Limited

Stephen Berezenko

John Rodney Woodrow

Richard A Johnson

Alan Victor Quirk

Hendrik Van Urk

Patricia Carol Wood

Andrew Robert Goodey

Darrell Sleep

Stephen James Burton

Mark J Wilson

David James Ballance

Steven James Burton

Jason Cameron

Philip Harvey Morton

Andrew John Cartwright

Jean-Luc Bernard Veron

Darell Sleep

David St Coghlan

David John Mead

Michael Gaston Joseph Grandgeorge

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 is 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.

A process is provided for the preparation of albumin from a yeast culture medium which has extremely low levels of or is essentially free of colorants, metal ions, human proteins, host proteins, fragments of albumin, polymers or aggregates of albumin and viruses, and which is essentially non-glycated, relatively high in free thiol and with an intact C-terminus. The process comprises separating the yeast from the culture medium to yield an albumin solution; subjecting the albumin solution to positive mode cation exchange, affinity, and positive mode anion exchange chromatography; and concentrating and formulating the albumin with sodium octanoate and sodium chloride.

Process of high purity albumin production

A process is provided for the preparation of albumin which has extremely low levels of or is essentially free of colorants, metal ions, human proteins, host proteins, fragments of albumin, polymers or aggregates of albumin and viruses, and which is essentially non-glycated, relatively high in free thiol and with an intact C-terminus. The process comprises passing albumin (preferably expressed and secreted by transformed yeast) through positive mode cation exchange and then positive mode anion exchange chromatography. Other steps may also be employed, ultrafiltration, gel permeation chromatography, affinity chromatography binding the albumin by using blue dyes) and affinity chromatography binding contaminants by using an aminophenylboronic acid resin. Elution of albumin, with a compound having affinity for albumin, from a material having no specific affinity for albumin is also disclosed, as is removal of ammonium ions with a counter-ion.

The present invention relates to a process for purifying the protein human serum albumin extracted from serum or recombinant human albumin produced by transforming a microorganism with a nucleotide coding sequence encoding the amino acid sequence of human serum albumin. The present invention provides highly purified albumin.

A process is provided for the preparation of albumin which has extremely low levels of or is essentially free of colorants, metal ions, human proteins, fragments of albumin, polymers or aggregates of albumin, and viruses, and which is relatively non-glycated, relatively high in free thiol and with an intact C-terminus. The process comprises passing albumin (preferably expressed and secreted by transformed yeast) through two chromatography purifications, ultrafiltering the product, passing through two further chromatography steps and again ultrafiltering the product.

High purity albumin

A process for the preparation of albumin which has extremely low levels of or is essentially free of colorants, metal ions, human proteins, fragments of albumin, polymers or aggregates of albumin, and viruses, and which is relatively non-glycated, relatively high in free thiol and with an intact C-terminus. The process comprises passing albumin (preferably expressed and secreted by transformed yeast) through two chromatography purifications, ultrafiltering the product, passing through two further chromatography steps and again ultrafiltering the product.

High purity albumin and method of producing

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Loughborough, United Kingdom

Stephen Berezenko