Co-formulated Anti-LAG3 and Anti-PD-1 Antibody Stability
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Solution Overview
Problem
Current formulations of therapeutic antibodies, such as anti-LAG3 and anti-PD-1 antibodies, face challenges in achieving stability and maintaining efficacy over a long shelf-life, particularly when stored at refrigerator temperature in a syringe.
Innovation Solution
The development of co-formulations comprising anti-LAG3 antibodies or antigen binding fragments and anti-PD-1 antibodies or antigen binding fragments, specifically formulated with components like polysorbate 80, L-arginine, and a buffer at pH 4.5-6.5, which enhance stability and maintain biological activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If individual antibody formulations are used, then formulation development is simpler, but stability and shelf-life are insufficient
Solution Approach 1:
The patent combines two different antibodies (anti-LAG3 and anti-PD-1) into a single co-formulation system. This merging approach allows both antibodies to benefit from the same optimized formulation conditions (pH 4.5-6.5, specific excipients), thereby improving the stability and shelf-life of both antibodies simultaneously while managing the complexity through a unified formulation strategy.
Solution Approach 2:
The patent identifies and applies specific formulation parameters (pH range of 4.5-6.5, presence of polysorbate 80, L-arginine, and other excipients) that optimize the stability of the co-formulated antibodies. By carefully controlling these parameters, the formulation achieves enhanced stability and extended shelf-life compared to individual formulations, resolving the contradiction between reliability and complexity.
2Duration of action of stationary object
If co-formulations are developed, then stability is improved, but formulation development becomes more complex
Solution Approach 1:
The patent performs preliminary screening and optimization of formulation conditions before finalizing the co-formulation. By pre-testing different pH values, excipient combinations, and concentrations, the developers identified the optimal formulation parameters (pH 4.5-6.5, specific excipients) that maximize shelf-life. This preliminary action reduces the complexity of subsequent manufacturing by establishing a well-defined formulation protocol.
Solution Approach 2:
The co-formulation system is designed to serve multiple functions: it stabilizes both anti-LAG3 and anti-PD-1 antibodies simultaneously, provides long-term storage capability, and maintains biological activity. The formulation components (buffer system, excipients) are selected to perform multiple protective functions, thereby extending shelf-life while managing development complexity through a multi-functional approach.
3Reliability
If storage conditions are optimized, then biological activity is maintained, but storage flexibility is reduced
Solution Approach 1:
The patent optimizes the formulation parameters (pH 4.5-6.5, specific excipients like polysorbate 80 and L-arginine) to create a stable environment that maintains biological activity of the antibodies during storage. By adjusting these parameters, the formulation achieves enhanced stability without requiring extreme storage conditions, thereby balancing reliability with practical storage flexibility.
Data Source
AI summary
The present invention provides co-formulations of anti-PD-1 antibodies and anti-LAG3 antibodies, and their use in treating various disorders.