PVRIG/TIGIT Bispecific Antibody Formulation for Thermal Stability

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Solution Overview

Problem

Existing formulations of PVRIG/TIGIT bispecific antibodies face stability challenges due to protein instability, leading to aggregation and making transportation and storage costly and inefficient.

Innovation Solution

A pharmaceutical composition comprising a PVRIG/TIGIT bispecific antibody, a buffer, a non-reducing sugar, and a non-ionic surfactant, specifically formulated to maintain stability at various temperatures and enhance storage longevity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If PVRIG/TIGIT bispecific antibody is formulated without special stabilizing agents, then the formulation is simple, but the antibody forms particles and aggregates due to protein instability

Engineering Contradiction:

Improveformulation complexityVSAvoidantibody stability

Core Design Contradiction:

Device complexityVSStability of the object's composition

Solution Approach 1:

The patent introduces multiple intermediary substances (sugars like sucrose and trehalose, amino acids like arginine and histidine, surfactants like polysorbate 80 and poloxamer 407, and buffers) that act as mediators between the antibody and the environment, preventing direct harmful interactions that lead to aggregation and particle formation

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The formulation uses composite material strategies by combining multiple excipients with different functions (stabilizers, surfactants, buffers) to create a synergistic system that provides comprehensive protection against various degradation mechanisms including aggregation, oxidation, and hydrolysis

Inventive Principle:

Principle #40Composite materials

2Stability of the object's composition

If refrigerated storage is used to maintain antibody stability, then the antibody remains stable, but transportation and storage costs increase

Engineering Contradiction:

Improveantibody stabilityVSAvoidtransportation and storage cost

Core Design Contradiction:

Stability of the object's compositionVSLoss of energy

Solution Approach 1:

The formulation fundamentally changes the stability parameters of the antibody by adjusting pH (using buffers like acetate, citrate, or phosphate at optimized concentrations), controlling ionic strength, and incorporating stabilizing excipients that enable the antibody to maintain stability across a broader temperature range, including room temperature and elevated temperatures up to 40°C

Inventive Principle:

Principle #35Parameter changes

3Productivity

If high concentration of antibody is formulated, then treatment efficiency is improved, but protein aggregation increases

Engineering Contradiction:

Improvetreatment efficiencyVSAvoidaggregation tendency

Core Design Contradiction:

ProductivityVSStability of the object's composition

Solution Approach 1:

Surfactants (polysorbate 80, poloxamer 407) and stabilizing excipients (sugars, amino acids) act as intermediaries at the protein-protein interface, preventing direct aggregation even at high concentrations by providing steric and electrostatic repulsion barriers

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The formulation optimizes multiple parameters simultaneously including pH (adjusted to specific ranges using buffers), ionic strength, and excipient concentrations to create a stable environment that allows high antibody concentrations (10-100 mg/mL) without precipitation or aggregation

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20260041765A1Pharmaceutical composition of pvrig/tigit bispecific antibody and use thereof

Publication Date: 2026.02.12 SHANDONG SIMCERE BIO PHARMA CO LTD

AI summary

Provided are a pharmaceutical composition of a PVRIG/TIGIT bispecific antibody and use thereof. Specifically, provided is a pharmaceutical composition, comprising a PVRIG/TIGIT bispecific antibody and a buffer solution. The pharmaceutical composition further comprises a sugar and a surfactant. Also provided is a pharmaceutical composition for treating cancer or infectious diseases.