Comprehensive Analysis of United States Patent 4,534,972: Chromatographic Methods for Protein Purification
Introduction
United States Patent 4,534,972, titled "Chromatographic Method for Purification of Proteins," was granted on August 13, 1985, to Lembach and assigns. This patent is significant in the field of biotechnology, particularly in the purification of proteins, which is a crucial step in the production of therapeutic proteins and other biopharmaceuticals.
Background of the Invention
The patent addresses the need for efficient and high-yield methods for purifying proteins. Prior to this invention, protein purification methods often resulted in low yields and were not highly specific, leading to contamination and reduced product quality. The background section of the patent highlights the limitations of earlier methods, such as the use of carboxylic acids for precipitation, which were not always effective in removing impurities[4].
Summary of the Invention
The patent describes a chromatographic method for the purification of proteins, particularly focusing on the use of ion exchange chromatography. Here are the key aspects of the invention:
Chromatographic Process
The method involves several chromatographic steps to achieve high purity and yield of the target protein. The process typically starts with a capture step, such as Protein A affinity chromatography, followed by ion exchange chromatography. The ion exchange chromatography can be either cation or anion exchange, with anion exchange chromatography (AEX) being particularly emphasized[1][4].
Anion Exchange Chromatography (AEX)
AEX is highlighted as a critical step in the purification process. The patent specifies the use of Tris hydrochloride at a pH range of about 8.3 to 8.6 for equilibrating the AEX column. This condition is crucial for optimizing the binding and elution of the target protein[1].
Additional Chromatographic Steps
In addition to AEX, the patent mentions the use of other chromatographic techniques such as mixed-mode or multimodal chromatography. These methods can further enhance the purity and yield of the protein by exploiting different properties of the protein, such as charge, size, and hydrophobicity[1][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: General Method
The first claim describes the general method of purifying proteins using a combination of chromatographic steps, including affinity chromatography and ion exchange chromatography[4].
Claim 2: Specific Conditions
Subsequent claims specify the conditions under which the chromatography is performed, including the use of Tris hydrochloride and the pH range for AEX[4].
Claim 3: Additional Steps
Other claims cover additional chromatographic steps and the use of different types of chromatography, such as mixed-mode chromatography[4].
Patent Landscape Analysis
To understand the significance and impact of this patent, it is essential to analyze the broader patent landscape in the field of protein purification.
Innovation Trends
The patent landscape in biotechnology, particularly in protein purification, has seen significant innovation over the years. Patents like 4,534,972 have contributed to the development of more efficient and specific purification methods. Recent patents, such as those related to anti-VEGF protein compositions, continue to build on these foundational methods[1][5].
Competitive Impact
Using tools like PatentSight, one can evaluate the competitive impact of this patent. The patent's significance can be measured by the number of times it has been cited by subsequent patents and its protection in various geographic territories. This analysis helps in understanding the patent's influence on the field and its potential value to competitors and allies[3].
Global Patent Filing Trends
The global patent landscape in biotechnology is vast and dynamic. Patents related to protein purification are filed by various companies and research institutions worldwide. Analyzing these trends can provide insights into where innovation is happening and who the key players are[3].
Impact on Industry
The methods described in this patent have had a substantial impact on the biotechnology industry:
Improved Yields and Purity
The use of ion exchange chromatography, particularly AEX, has significantly improved the yields and purity of therapeutic proteins. This has been crucial for the production of high-quality biopharmaceuticals[1][4].
Cost Reduction
Efficient purification methods reduce the overall cost of production. By minimizing the number of steps and optimizing each step, companies can lower their operational costs and make biopharmaceuticals more affordable[4].
Regulatory Compliance
High-purity proteins are essential for meeting regulatory standards. The methods described in this patent help ensure that the final product meets the stringent requirements set by regulatory bodies, such as the FDA[4].
Critique and Limitations
While the patent has been instrumental in advancing protein purification, there are some limitations and areas for critique:
Complexity of the Process
The multi-step chromatographic process can be complex and requires specialized equipment and expertise. This can be a barrier for smaller research institutions or companies with limited resources[4].
Scalability
Scaling up the purification process from laboratory to industrial scale can be challenging. The patent does not provide detailed guidance on how to scale up the process efficiently[4].
Key Takeaways
- Efficient Purification Method: The patent describes a highly efficient method for purifying proteins using ion exchange chromatography.
- Improved Yields and Purity: The method significantly improves the yields and purity of therapeutic proteins.
- Cost Reduction: Efficient purification reduces operational costs.
- Regulatory Compliance: The method helps ensure compliance with regulatory standards.
- Complexity and Scalability: The process can be complex and challenging to scale up.
FAQs
Q: What is the main focus of United States Patent 4,534,972?
A: The main focus is on a chromatographic method for the purification of proteins, particularly using ion exchange chromatography.
Q: What is the significance of anion exchange chromatography (AEX) in this patent?
A: AEX is highlighted as a critical step for optimizing the binding and elution of the target protein, using Tris hydrochloride at a specific pH range.
Q: How has this patent impacted the biotechnology industry?
A: It has improved yields and purity of therapeutic proteins, reduced production costs, and helped in meeting regulatory standards.
Q: What are some limitations of the method described in the patent?
A: The process can be complex and requires specialized equipment and expertise, and scaling up the process can be challenging.
Q: How can the competitive impact of this patent be evaluated?
A: Using tools like PatentSight, which measure the patent’s significance by citations, geographic protection, and market size.
Sources
- Anti-VEGF protein compositions and methods for producing the same. Justia Patents.
- Low acidic species compositions and methods for producing and using the same. Justia Patents.
- Patent Landscape Analysis. LexisNexis IP.
- Chromatographic Method for High Yield Purification and Viral Inactivation of Antibodies. Google Patents.
- ANTI-VEGF PROTEIN COMPOSITIONS AND METHODS FOR PRODUCING THE SAME. Canadian Patents Database.
