Fixed-Dose Antibody Formulation for Stable Co-Administration
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Solution Overview
Problem
Administering combinations of immune checkpoint antibodies, such as anti-PD-1 and anti-CTLA-4 antibodies, is burdensome due to different dosing requirements and stability profiles, making a single formulation challenging due to variations in physicochemical properties.
Innovation Solution
A pharmaceutical composition with a fixed dose formulation of an anti-PD-1 antibody and a second antibody, such as anti-CTLA-4, at specific ratios (e.g., 50:1 to 1:50) with additional components like buffering agents, stabilizing agents, and surfactants to enhance stability and convenience.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single formulation containing two antibodies is used, then convenience and administration burden are improved, but formulation stability and compatibility deteriorate due to different physicochemical properties
Solution Approach 1:
The formulation is segmented into separate antibody components that can be independently optimized for stability, with each antibody maintained in its own stable concentration range rather than forcing a single unified formulation composition
Solution Approach 2:
The patent applies parameter changes by establishing specific concentration ratios (X:Y ratio) and pH ranges (5.0-7.0) that optimize the stability of both antibodies simultaneously, allowing different physicochemical properties to coexist in a stable formulation
2Manufacturing precision
If fixed dose formulation is used, then dosing accuracy and compliance are improved, but flexibility in customization deteriorates
Solution Approach 1:
The formulation transitions from a static fixed dose to a dynamic dosing system where the X:Y ratio can be adjusted within specific ranges while maintaining stability, allowing customization based on patient needs while preserving manufacturing precision
Solution Approach 2:
The fixed dose formulation serves multiple functions by providing both dosing accuracy for compliance and a flexible framework for customization through adjustable ratios within defined parameters
3Adaptability or versatility
If two antibodies are administered separately, then dosing flexibility is maintained, but administration burden and time deteriorate
Solution Approach 1:
The patent merges two separate antibody administrations into a single combined formulation, reducing administration time and burden while maintaining dosing flexibility through adjustable X:Y ratios within specific ranges
4Ease of operation
If antibody combinations are formulated, then administration convenience is improved, but interaction between antibodies with different stability profiles deteriorates
Solution Approach 1:
The formulation acts as an intermediary medium that accommodates both antibodies with different stability profiles by controlling pH, concentration ratios, and other parameters to prevent harmful interactions while maintaining individual antibody stability
Solution Approach 2:
Parameter changes are applied by establishing specific pH ranges (5.0-7.0) and concentration ratios that optimize the stability of both antibodies, allowing them to coexist without compromising reliability
Data Source
AI summary
This provides pharmaceutical compositions that comprise a combination of an anti-cancer agent which is an first antibody and a second antibody. In some embodiments, the first antibody is an anti-Programmed Death-1 (PD-1) antibody. In certain embodiments, the composition is a fixed dose formulation. In certain embodiments, the composition is administered as a flat-dose. The disclosure also provides a kit for treating a subject afflicted with a disease, the kit comprising a dosage of any composition disclosed herein and instructions for using the composition in any of the disclosed methods for treating a disease.