Enhanced Pharmaceutical Compositions with Improved Stability and Processability

The present inventive concept relates to novel pharmaceutical compositions comprising an antibody, glycine, acetate buffer, and polysorbate 80, with added features that enhance the stability, processability, and administration of the composition.

The original patent disclosed pharmaceutical compositions with an antibody, glycine, acetate buffer, and polysorbate 80. However, these compositions had limitations in terms of stability, processability, and administration. The present inventive concept addresses these limitations by introducing pH-stabilizing agents, optimizing viscosity, and increasing protein concentration.

The new claims introduce several enhancements to the original pharmaceutical compositions. Claim 1 adds a pH-stabilizing agent to enhance the stability of the antibody at a temperature range of 2-25°C. Claim 2 describes a method for preparing the composition, involving the addition of a stabilizing agent to improve long-term stability. Claim 3 formulates the composition to have a viscosity of less than 10 cP at 25°C, improving processability. Claim 4 provides a system for storing the composition, maintaining a temperature range of 2-8°C to optimize stability. Claim 5 increases the protein concentration to at least 200 mg/mL, reducing the volume of administration.

The new claims provide a novel and non-obvious combination of features that improve the stability, processability, and administration of pharmaceutical compositions. The addition of pH-stabilizing agents, optimization of viscosity, and increase in protein concentration provide a significant enhancement over the original patent.

Alternative embodiments may include the use of different pH-stabilizing agents, varying the concentration of glycine and acetate buffer, or incorporating additional excipients to further improve stability and processability. Variations may also include different antibody formats, such as fragments or conjugates, or different routes of administration.

The enhanced pharmaceutical compositions have significant commercial potential in the biopharmaceutical industry, particularly for the treatment of autoimmune diseases. The improved stability, processability, and administration of these compositions can reduce production costs, increase patient compliance, and expand market opportunities.