Enhanced Pharmaceutical Compositions with Improved Stability and Processability
Legal Citation
Summary of the Inventive Concept
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.
Background and Problem Solved
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.
Detailed Description of the Inventive Concept
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.
Novelty and Inventive Step
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 and Variations
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.
Potential Commercial Applications and Market
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.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K39/39591 |
| A | A61 | A61K47/12 |
| A | A61 | A61K47/183 |
| A | A61 | A61K47/26 |
| C | C07 | C07K16/244 |
| C | C07 | C07K2317/76 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical biotechnology, specifically antibody formulation and protein therapeutic composition design, involving protein stabilization, buffer systems, and excipient optimization
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with expertise in protein engineering, formulation chemistry, and biologic drug development, holding a PhD or equivalent advanced degree with 3-5 years of specialized experience in antibody therapeutic development
Obviousness Rationale
A PHOSITA would recognize that the published technical disclosure represents predictable variations in pharmaceutical composition design, leveraging known stabilization techniques and formulation strategies that are routine optimization approaches in antibody therapeutic development. The disclosed modifications represent incremental improvements using standard techniques known in the art for enhancing protein stability, processability, and administration. These variations would be considered obvious extensions of the foundational pharmaceutical composition disclosed in the source patent.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,625 |
|---|---|
| Title | Pharmaceutical compositions |
| Assignee(s) | UCB BIOPHARMA SRL |