Anti-CD200 Antibody Liquid Formulation Stability
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Solution Overview
Problem
Current liquid pharmaceutical formulations of anti-CD200 antibodies are unstable at standard storage and shipping conditions (2-8°C), leading to physical and chemical degradation, aggregation, and limited concentration, which restricts their therapeutic use.
Innovation Solution
Development of liquid formulations containing anti-CD200 antibodies or antigen binding fragments, combined with non-ionic surfactants, polyols, and citrate or acetate buffers, which maintain stability and concentration, reducing aggregation and preserving biological activity for extended periods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If liquid formulations of anti-CD200 antibodies are stored at standard refrigerated conditions (2-8°C), then the formulations are convenient for storage and shipping, but the antibodies undergo physical and chemical degradation, aggregation, and precipitation
Solution Approach 1:
The patent introduces intermediary substances (surfactants like polysorbate 80, stabilizers like histidine or glycine, and buffers like citrate or acetate) that mediate between the antibody and the storage environment. These intermediaries protect the antibody from degradation and aggregation during refrigerated storage, enabling stable liquid formulations at 2-8°C without requiring alternative storage conditions.
2Quantity of substance
If the concentration of anti-CD200 antibody in liquid formulations is increased to improve therapeutic efficacy, then the therapeutic dose can be delivered in smaller volumes, but the formulations become less stable and more prone to aggregation
Solution Approach 1:
The patent systematically optimizes multiple formulation parameters including pH (adjusted to specific ranges using citrate or acetate buffers), ionic strength, presence of stabilizing agents at optimized concentrations, and temperature conditions. By changing these parameters in combination, the formulation achieves both high antibody concentration (e.g., 10-100 mg/mL) and enhanced stability, preventing aggregation even at elevated concentrations.
3Duration of action of stationary object
If extended storage periods are required for distribution and clinical use, then the formulations need to remain stable for months, but antibodies are prone to gradual degradation over time
Solution Approach 1:
The patent incorporates preliminary protective measures in the formulation design, including pre-added stabilizers (histidine, glycine, sucrose), surfactants (polysorbate 80 at optimized concentrations), and buffers (citrate or acetate) that are present from the outset. These agents preemptively protect the antibody against degradation mechanisms that would otherwise occur during extended storage, maintaining biological activity for periods exceeding 6 months at refrigerated temperatures.
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
The formulations achieve stability for at least 9 to 24 months at 2-8°C, with low to undetectable levels of aggregation and preservation of biological activity, enabling higher concentrations and improved therapeutic efficacy.
Implementation Method 1
liquid formulations containing anti-CD200 antibodies or antigen binding fragments, combined with non-ionic surfactants, polyols, and citrate or acetate buffers
Implementation Method 2
combined with non-ionic surfactants, polyols, and citrate or acetate buffers
Implementation Method 3
combined with non-ionic surfactants, polyols, and citrate or acetate buffers
Data Source
AI summary
The present disclosure provides stable liquid pharmaceutical formulations comprising anti-CD200 antibodies or antigen-binding fragments thereof, and articles of manufacture and kits containing the formulations. Also featured are methods of using the formulations in cancer and autoimmune therapies, and for preventing, delaying or treating cell, tissue, or organ transplant rejection.