CD147 Monoclonal Antibody Formulation Stability
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Solution Overview
Problem
Monoclonal anti-CD147 antibodies are prone to instability due to aggregation, leading to undesired immunological reactions and safety concerns in liquid formulations, necessitating stable and quality-consistent pharmaceutical formulations.
Innovation Solution
A stable pharmaceutical formulation comprising a monoclonal anti-CD147 antibody, a buffer, a protein protective agent, and a surfactant, specifically using a succinate buffer, trehalose as the protein protective agent, and polysorbate 20 as the surfactant, with a pH range of 5.0-6.0, to maintain stability and consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If monoclonal anti-CD147 antibody is formulated in liquid form, then it can be administered to patients, but it is prone to aggregation and instability leading to undesired immunological reactions
Solution Approach 1:
The patent introduces multiple excipients as intermediary substances to mediate between the antibody and the aqueous environment. These include surfactants (polysorbate 20, polysorbate 80, poloxamer 188) that form protective interfaces, amino acids (arginine, histidine, lysine, ornithine) that act as molecular spacers, and sugars (sucrose, trehalose, lactose, maltose, glucose) that provide structural support and prevent aggregation. These intermediaries collectively stabilize the antibody in liquid formulation without compromising administerability.
Solution Approach 2:
The patent creates a composite pharmaceutical formulation system combining the monoclonal anti-CD147 antibody with multiple stabilizing excipients. The formulation comprises a complex mixture of antibody protein, surfactants, amino acids, sugars, and buffers that work synergistically. This composite material approach transforms the unstable pure antibody into a stable multi-component system suitable for liquid administration while preventing aggregation and immunological reactions.
2Reliability
If antibody molecules are used in liquid formulation, then they can block CD147 target function, but their complex multilevel structure causes physical sticking and aggregation
Solution Approach 1:
The patent extracts and addresses the aggregation problem by separately optimizing the excipient composition. Instead of modifying the antibody structure itself, the formulation extracts the stabilizing function into dedicated excipients (surfactants, amino acids, sugars) that specifically target aggregation prevention while leaving the antibody's target-blocking function intact. This separation allows the antibody to maintain its therapeutic function without suffering from aggregation issues.
Solution Approach 2:
The patent optimizes multiple formulation parameters simultaneously: pH (adjusted to specific ranges using buffers), ionic strength, surfactant concentration, amino acid concentration, and sugar concentration. By carefully controlling these parameters, the formulation maintains the antibody's functional conformation for target blocking while preventing physical aggregation. The specific parameter optimization creates a stable environment that preserves both function and physical integrity.
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 formulation maintains the stability and functional activity of the monoclonal anti-CD147 antibody over a long period, remaining stable at low temperatures, during dilution, and under illumination, ensuring safety and efficacy in treatment applications.
Implementation Method 1
a buffer, a protein protective agent and a surfactant, specifically using a succinate buffer
Implementation Method 2
trehalose as the protein protective agent
Implementation Method 3
polysorbate 20 as the surfactant
Data Source
AI summary
Disclosed is a pharmaceutical preparation comprising a CD147 monoclonal antibody, a buffer, a protein protectant and a surfactant. The pharmaceutical preparation can maintain the stability of the CD147 monoclonal antibody over a long period of time. Also disclosed are the use of the pharmaceutical preparation in the preparation of a drug for treating CD147-related diseases, in particular non-small cell lung cancer, and a method for preparing the pharmaceutical preparation.