Abstract: A DNA construct for expressing a recombinant protein, wherein the DNA construct comprises: —at least one of the nucleotide sequences of SEQ ID No 20 and 21, wherein a nucleotide sequence of SEQ ID 20 and 21 is a TIR sequence; and —a nucleotide sequence which encodes a signal peptide; and wherein a nucleotide sequence of SEQ ID No 20 and 21 comprises at least the first 9 nucleotides of said signal peptide encoding sequence.
Type:
Application
Filed:
September 23, 2022
Publication date:
December 4, 2025
Applicants:
Xbrane Biopharma AB, Alvotech HF
Inventors:
Kiavash Mirzadeh, David Vikström, Nurzian Ismail, Patrik Samuelson, Mariusz Baraszkiewicz, Tagrid Salih, Kathleen Szekér, Daniel Chui, Santhosh Gudise, Per Edebrink, Maria Kadow, Karin Stefansson, Kristin Strandberg
Abstract: A pharmaceutical composition comprises a buffer-less aqueous formulation of adalimumab, a salt, a polyol, and a polysorbate. The formulation is suitable for injection.
Abstract: An autoinjector housing includes a cylindrical case enclosing an interior space capable of accommodating an autoinjector mechanism, a cylindrical cap removably attachable to the cylindrical case, and optionally a cylindrical overmolding. An exterior cross-sectional shape of the cylindrical case is oblong along at least a portion of its axis. An exterior cross-sectional shape of the cylindrical cap may be varied along its axis such that there is a gradual decrease in cross-sectional area from an open end toward a closed end and a step-up in cross-sectional area approaching the closed end. An end of the cylindrical case may be covered by the cylindrical overmolding, which may have non-uniform radial thickness and may be made of a material having elasticity.
Abstract: The present invention relates to stable, aqueous formulations of adalimumab. Particularly, stable, aqueous formulations comprising high concentration (e.g. about 100 mg) of adalimumab, trehalose or sucrose, nonionic surfactant, low concentration to no buffer, with no ionic tonicity-adjusting agents and no amino acid stabilizers.
Abstract: A pharmaceutical composition comprises a buffer-less aqueous formulation of adalimumab, a salt, a polyol, and a polysorbate. The formulation is suitable for injection.
Abstract: A pharmaceutical composition comprises a buffer-less aqueous formulation of adalimumab, a salt, a polyol, and a polysorbate. The formulation is suitable for injection.