Advanced Antibody Formulations for Enhanced Stability and Shelf-Life
Legal Citation
Summary of the Inventive Concept
The present inventive concept relates to novel antibody compositions with adjustable pH ranges, optimized storage conditions, and advanced excipient combinations to ensure maximum stability and shelf-life, thereby revolutionizing the pharmaceutical industry.
Background and Problem Solved
The original patent disclosed a pharmaceutical composition comprising an antibody, glycine, acetate buffer, and polysorbate 80. However, the composition's stability and shelf-life were limited by the fixed pH range and storage conditions. The new inventive concept addresses these limitations by introducing adjustable pH ranges, optimized storage conditions, and advanced excipient combinations, enabling the development of more robust and reliable pharmaceutical products.
Detailed Description of the Inventive Concept
The novel antibody composition comprises an antibody or antigen-binding fragment thereof, glycine, acetate buffer, and polysorbate 80, with an adjustable pH range from 4.0 to 6.0. The antibody is modified to have enhanced stability at varying temperatures and storage conditions. The composition can be optimized for specific antibodies or antigen-binding fragments, ensuring maximum stability and shelf-life. Additionally, the inventive concept encompasses a method for optimizing storage conditions, a pharmaceutical composition with novel excipients, a system for real-time monitoring of composition stability, and a method for predicting and preventing protein degradation.
Novelty and Inventive Step
The new claims introduce a paradigm shift in pharmaceutical composition development by providing adjustable pH ranges, optimized storage conditions, and advanced excipient combinations. These innovations enable the creation of more stable and reliable pharmaceutical products, overcoming the limitations of the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different antibodies or antigen-binding fragments, varying excipient combinations, and adjustable pH ranges tailored to specific disease indications. Variations could also include the integration of machine learning algorithms and molecular modeling to predict and prevent protein degradation.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the development of novel treatments for autoimmune diseases, cancer, and inflammatory disorders. The target market includes pharmaceutical companies, biotechnology firms, and research institutions seeking to develop more robust and reliable pharmaceutical products.
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 stabilization, involving advanced drug delivery systems and protein engineering techniques
Person of Ordinary Skill (PHOSITA) Profile
A professional with advanced degrees in biochemistry or pharmaceutical sciences, expertise in protein chemistry, formulation development, and experience with monoclonal antibody production and stabilization techniques
Obviousness Rationale
A person having ordinary skill would recognize that the PTD represents predictable variations of the source patent's antibody composition by systematically exploring known strategies for enhancing protein stability through excipient combinations, pH adjustments, and advanced monitoring techniques. The disclosed modifications represent standard engineering approaches in pharmaceutical formulation that would be apparent to a skilled practitioner seeking to optimize antibody compositions. The PTD's variations demonstrate incremental improvements using well-established pharmaceutical development methodologies.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,625 |
|---|---|
| Title | Pharmaceutical compositions |
| Assignee(s) | UCB BIOPHARMA SRL |