IL-13 Antibody Purification Single Buffer System
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Solution Overview
Problem
Current antibody purification processes for IL-13 antibodies require multiple buffers and separation techniques, leading to increased processing time and cost, and reduced product yield.
Innovation Solution
A pharmaceutical composition using a single 50mM sodium acetate buffer at pH 4.5 to 6.0, including 85mM sodium chloride and 0.01% polysorbate 80, throughout the purification process, simplifying and streamlining the purification steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple buffers and separation techniques are used in antibody purification, then purification effectiveness is improved, but processing time increases and product yield decreases
Solution Approach 1:
The patent combines multiple purification steps (Protein A chromatography, viral inactivation, and concentration) into a single integrated process using one buffer system. The acetate buffer at pH 3.5-5.0 serves multiple functions simultaneously: it enables Protein A binding, maintains viral inactivation conditions, and supports concentration operations, thereby eliminating the need for buffer exchanges and reducing processing time
Solution Approach 2:
The acetate buffer system is designed to perform multiple functions across different purification stages. A single buffer composition (50mM sodium acetate, 85mM sodium chloride, 0.01% polysorbate 80 at pH 4.5-6.0) universally supports affinity chromatography, viral inactivation, and concentration operations, replacing the traditional requirement for multiple specialized buffers
2Manufacturing precision
If multiple buffers and separation techniques are used in antibody purification, then purification effectiveness is improved, but production cost increases
Solution Approach 1:
The patent consolidates multiple purification operations into a single buffer system, reducing the number of consumables (buffers, chromatography media) required. By performing Protein A purification, viral inactivation, and concentration in one integrated process using acetate buffer, the patent reduces material costs and processing expenses associated with multiple separate steps
Solution Approach 2:
The integrated buffer system allows for recovery and reuse of the acetate buffer across multiple purification steps. Instead of discarding and replacing buffers between operations, the same buffer composition is maintained throughout the process, reducing waste disposal costs and buffer purchase expenses
3Manufacturing precision
If multiple buffers and separation techniques are used in antibody purification, then purification effectiveness is improved, but product yield decreases
Solution Approach 1:
The patent combines purification and concentration steps into one integrated process using the acetate buffer system. By maintaining the antibody in the same buffer throughout Protein A chromatography, viral inactivation, and concentration operations, the patent eliminates transfer losses and minimizes product degradation that would occur during multiple buffer exchanges and separations
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach reduces processing time and cost while increasing product yield by maintaining a consistent buffer throughout the purification process, enhancing the efficiency of IL-13 antibody production.
Implementation Method 1
50mM sodium acetate buffer, 85mM sodium chloride and 0.01% polysorbate 80 buffered to a pH of 4.5 to 6.0 with said sodium acetate buffer
Implementation Method 2
0.01% polysorbate 80
Data Source
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AI summary
The invention relates to a pharmaceutical composition comprising an interleukin-13 antibody, more particularly a monoclonal interleukin-13 antibody, especially a human interleukin-13 monoclonal antibody, to a process for purifying said antibody and to the use of said composition in treating interleukin-13 related disorders, such as asthma, atopic dermatitis, allergic rhinitis, fibrosis, chronic obstructive pulmonary disease, scleroderma, inflammatory bowel disease and Hodgkin's lymphoma, particularly asthma.