Anti-PVRIG/TIGIT Bispecific Antibody Formulation Stability

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Solution Overview

Problem

Current formulations lack high-avidity, high-selectivity, and high-bioactivity anti-PVRIG/TIGIT bispecific antibodies capable of effectively inhibiting cancer or tumor growth in vivo.

Innovation Solution

A pharmaceutical composition comprising an anti-PVRIG/TIGIT bispecific antibody with specific antigen-binding domains and a buffer system, including histidine or acetate buffers, to maintain stability and efficacy, along with a surfactant and osmotic pressure regulator, is developed to enhance therapeutic activity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional formulations are used, then general stability is maintained, but high-avidity, high-selectivity, and high-bioactivity are not achieved

Engineering Contradiction:
ImprovebioactivityVSAvoidformulation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent optimizes specific formulation parameters including pH (5.0-7.5), buffer concentration (5-50 mM), surfactant concentration (0.01-1%), and osmotic pressure (200-400 mOsm) to achieve high bioactivity while maintaining formulation simplicity. These parameter optimizations enable the anti-PVRIG/TIGIT bispecific antibody to achieve high-avidity and high-selectivity without requiring complex formulation systems.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If buffer system is added to maintain stability, then pH control is improved, but formulation complexity increases

Engineering Contradiction:
ImprovepH stabilityVSAvoidformulation complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent specifies optimal pH ranges (5.0-7.5) and buffer concentrations (5-50 mM) to achieve adequate pH stability without requiring complex buffer systems. This parameter optimization provides sufficient pH control while maintaining formulation simplicity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs simple, commonly available buffer systems (histidine, acetate, or phosphate buffers) that are easy to prepare and maintain stability during storage and administration, avoiding the need for complex or specialized buffering systems.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If surfactant and osmotic pressure regulator are added, then therapeutic activity is enhanced, but formulation complexity increases

Engineering Contradiction:
Improvetherapeutic activityVSAvoidformulation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent optimizes surfactant concentrations (0.01-1%) and osmotic pressure (200-400 mOsm) to achieve enhanced therapeutic activity while maintaining formulation simplicity. These parameter ranges provide adequate stabilization and therapeutic effect without requiring complex formulation systems.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs common, readily available excipients including surfactants (polysorbate 20, polysorbate 80, poloxamer 188) and osmotic pressure regulators (sucrose, glucose, sodium chloride) that are easy to source and incorporate, avoiding the need for specialized or complex stabilization systems.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Data Source

PatentUS20240376207A1Pharmaceutical composition comprising Anti-pvrig/tigit bispecific antibody
Publication Date: 2024.11.14 JIANGSU HENGRUI MEDICINE CO LTD
  • US20240376207A1 patent drawing
  • US20240376207A1 patent drawing
  • US20240376207A1 patent drawing

AI summary

A pharmaceutical composition comprising an anti-PVRIG/TIGIT bispecific antibody.