Baxter International Inc.

Baxter Healthcare Sa

Takeda Pharmaceutical Company Limited

Ology Bioservices Inc.

Michael Graninger

Artur Mitterer

Meinhard Hasslacher

Christian Fiedler

Ernst Boehm

Roman Necina

Martin Kaliwoda

Marián BENDÍK

The disclosure relates to the development of improved methods for quantifying antigen in a vaccine composition in the absence of available antigen standards. More specifically, the disclosure provides fast and robust methods of separating antigens from vaccine compositions, comprising the steps of solubilizing antigen without detergent and without alkylation, using acidification to prevent antigen subtypes from binding again, isolating antigen subtypes with chromatography, and quantifying the eluted antigen with amino acid analysis. The methods of the disclosure are applicable for use with a variety of antigens, thereby providing an improved method in the art of vaccine manufacturing to date.

Methods for isolating and quantifying antigen from vaccines

The present invention relates to a proteinaceous construct comprising a blood coagulation factor, e.g., Factor VIII (FVIII), being bound to at least one water soluble polymer, including a poly(alkylene oxide) such as polyethylene glycol (PEG). Further the present invention relates to methods of preparing PEGylated blood coagulation factor, e.g., FVIII, in the presence of bound antibodies. The invention also relates to methods for prolonging the in vivo-half-life of blood coagulation factor, e.g., FVIII, in the blood of a mammal having a bleeding disorder associated with functional defects or deficiencies of blood coagulation factor, e.g., FVIII.

Pegylation of recombinant blood coagulation factors in the presence of bound antibodies

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Vienna, Austria

Michael Graninger