Fresenius Kabi Deutschland Gmbh

Ares Trading S.a.

Hervé Broly

Matthieu Stettler

Thomas Solacroup

Martin Jordan

David Bruhlmann

Harry-james Sutter

Yolande Rouiller

Thomas Vuillemin

Matteo Costioli

Gabrielle Leclercq

Jonathan Souquet

Anaïs Muhr

The present invention relates to a method for purifying adalimumab or a biosimilar thereof from a sample comprising adalimumab or a biosimilar thereof and impurities, through the use of hydroxyapatite resin in a Bind/Elute (B/E) mode under conditions such that the adalimumab or a biosimilar thereof binds to the resin and at least a portion of the impurities remain unbound. The invention is also concerned with a pharmaceutical compositions=of the purified adalimumab or a biosimilar thereof, and adalimumab or a biosimilar thereof obtainable by the process of the invention.

Methods of purifying and producing an adalimumab antibody

The present invention relates to methods and compositions for modulating mannosylation profile of recombinant proteins expressed by mammalian host cells during the cell culture process, using a polyether ionophore.

Methods for modulating protein mannosylation profiles using maduramycin, narasin, or salinomycin

The present invention relates to a method of maintaining cell viability at a level of at least 80% for up to 14 days in a fed-batch culture of cells producing a recombinant protein, the method comprising maintaining the cell culture medium at a pH of 6.5 to 7.0 and at a temperature of 31&#xb0; C. to 35&#xb0; C. for at least 5 consecutive days of the duration of the cell culture method.

Cell culture methods for increased cell viability

The present invention relates to a method of increasing biosimilarity of a TNF &#x3b1; binding protein to a reference TNF &#x3b1; binding protein by modifying the charge profile of the binding protein produced by cell culture in a cell culture medium, by making an adjustment to a cell culture condition The adjustment is an increase in the concentration of a metal ion in the cell culture medium and the adjustment occurs on one or more days during the cell culture method, whereby the adjustment in the cell culture condition results in the modification of the charge profile of the binding protein. The present invention also relates to a biosimilar protein obtainable by such a process.

Methods for increasing biosimilarity

The present invention relates to a method of reducing serine for asparagine misincorporation in a protein produced by a culture of cells in a cell culture method, the method comprising the addition of asparagine and iron to the cell culture medium.

Method of reducing serine for asparagine misincorporation

The present invention relates to a cell culture method for adjusting the proportion of G0, G1, G2, and high-mannose galactosylation variants in a population of a recombinant protein produced by a culture of cells in a cell culture medium by supplementing the cell culture medium with manganese at one or more days of the cell culture method duration.

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Chatel-St Denis, Switzerland

Hervé Broly