Abstract: 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.

Abstract: 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.

Abstract: 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° C. to 35° C. for at least 5 consecutive days of the duration of the cell culture method.

Abstract: The present invention relates to a method of increasing biosimilarity of a TNF ? binding protein to a reference TNF ? 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.

Abstract: The present invention relates to methods and compositions for modulating glycosylation profile, such as the galactosylation profile, of recombinant proteins expressed by mammalian host cells during the cell culture process by supplementing cell culture media with a peracetyl galactose.

Abstract: The present invention relates to a method for controlling the afucosylation level of a glycoprotein composition. The method comprises the control of the afucosylation level by selecting the appropriate temperature and/or pH. The invention also relates to glycoprotein compositions produced according to the method of the invention.

Abstract: 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.

Abstract: The invention is in the field of cell culture. Particularly the invention relates to methods of culturing a host cell expressing a recombinant protein in a cell culture medium comprising an effective amount of a triazine dye or supplemented with an effective amount of a triazine dye, whereby production of said protein is increased relative to cells grown without said triazine dye or any other inducer.

Abstract: The invention is in the field of cell culture. Particularly the invention relates to methods of culturing a host cell expressing a recombinant protein in a cell culture medium comprising an effective amount of 4,4?diisothiocyanostilbene-2,2?-disulfonic acid (DIDS) or supplemented with an effective amount of DIDS, whereby production of said protein is increased relative to cells grown without DIDS.

Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to methods and compositions for modulating glycosylation profile, such as the galactosylation profile, of recombinant proteins expressed by mammalian host cells during the cell culture process by supplementing cell culture media with a peracetyl galactose.

Abstract: The present invention relates to new serum- and protein-free culture media. These media are high performance culture media, which notably improve mammalian fed-batch cultures. The present invention also relates to methods for preparing and/or designing the medium, and methods of use thereof.

Abstract: The invention is in the field of cell culture. Particularly the invention relates to methods of culturing a host cell expressing a recombinant protein in a cell culture medium comprising an effective amount of 4,4?-diisothiocyanostilbene-2,2?-disulfonic acid (DIDS) or supplemented with an effective amount of DIDS, whereby production of said protein is increased relative to cells grown without DIDS.

Abstract: The invention is in the field of cell culture. Particularly the invention relates to methods of culturing a host cell expressing a recombinant protein in a cell culture medium comprising an effective amount of a triazine dye or supplemented with an effective amount of a triazine dye, whereby production of said protein is increased relative to cells grown without said triazine dye or any other inducer.

Abstract: The present invention relates to new serum- and protein-free culture media. These media are high performance culture media, which notably improve mammalian fed-batch cultures. The present invention also relates to methods for preparing and/or designing the medium, and methods of use thereof.

Abstract: The invention relates to novel combination therapies involving BLyS or BLyS/APRIL inhibition and anti-CD20 agents for the treatment of autoimmune diseases. One preferred method is where the BLyS antagonist is a Fc-fusion protein which can be a TACI-Fc-fusion protein comprising the extracellular domain of TACI or a functional fragment thereof, a BAFF-R-Fc-fusion protein comprising the extracellular domain of BAFF-R or a functional fragment thereof, or a BCMA-Fc-fusion protein comprising the extracellular domain of BCMA or a functional fragment thereof. In the methods of the present invention some of anti-CD20 agents contemplated include RITUXAN®, ocrelizumab, ofatumumab (HuMax-CD20®), TRU-015, and DXL625, although any agent that binds to CD 20 may be suitable. The methods of the present invention reduce the levels of B cells in patients in need of such reduction, such as those suffering from autoimmune diseases.

Abstract: The invention relates to novel combination therapies involving BLyS or BLyS/APRIL inhibition and anti-CD20 agents for the treatment of autoimmune diseases. One preferred method is where the BLyS antagonist is a Fc-fusion protein which can be a TACI-Fc-fusion protein comprising the extracellular domain of TACI or a functional fragment thereof, a BAFF—R-Fc-fusion protein comprising the extracellular domain of BAFF—R or a functional fragment thereof, or a BCMA-Fc-fusion protein comprising the extracellular domain of BCMA or a functional fragment thereof. In the methods of the present invention some of anti-CD20 agents contemplated include RITUXAN®, (rituximab),ocrelizumab, ofatumumab (HuMax-CD20®), TRU-015, and DXL625, although any agent that binds to CD 20 may be suitable. The methods of the present invention reduce the levels of B cells in patients in need of such reduction, such as those suffering from autoimmune diseases.

Abstract: The present invention provides methods and compositions for treatment of hyperproliferative disorders and cancers, including multiple myeloma and Waldenström's macroglobulinemia, comprising administering to a patient in need of the treatment a TACI-Ig fusion molecule in amount sufficient to suppress proliferation-inducing functions of BlyS and APRIL.

Abstract: In various embodiments, the present invention provides methods and compositions for treatment of autoimmune diseases, including rheumatoid arthritis, for example comprising administering to a patient in need of such treatment a TACI-Ig fusion molecule. In one embodiment, the TACI-Ig fusion molecule is administered in amount sufficient to slow, suppress or inhibit proliferation-inducing functions of BlyS and APRIL.