Stable formulation for recombinant Anti-PD-1 monoclonal antibody
A stable formulation for recombinant anti-PD-1 monoclonal antibodies, including a buffer, osmolarity regulator, stabilizer, and surfactant, addresses storage and transport instability, maintaining antibody stability and therapeutic efficacy for extended periods.
CA3180463CActive Publication Date: 2026-07-07SINO CELL TECH INC
Patent Information
- Authority / Receiving Office
- CA · CA
- Patent Type
- Patents
- Current Assignee / Owner
- SINO CELL TECH INC
- Filing Date
- 2021-06-17
- Publication Date
- 2026-07-07
AI Technical Summary
Technical Problem
Existing formulations of recombinant anti-PD-1 monoclonal antibodies suffer from instability during storage and transport, leading to reduced potency and increased immunogenicity, which compromises their therapeutic efficacy.
Method used
A stable formulation comprising a recombinant anti-PD-1 monoclonal antibody, a buffer, an osmolarity regulator, a stabilizer, and a surfactant, with specific concentration ranges and pH conditions, ensuring physical and chemical stability and biological activity.
Benefits of technology
The formulation maintains the antibody's stability and therapeutic activity for at least 42 months at 2-8°C and 12 months at 25°C, ensuring its effectiveness upon administration.
✦ Generated by Eureka AI based on patent content.
Abstract
Provided is a stable formulation for a recombinant monoclonal antibody, consisting of a recombinant anti-PD-1 monoclonal antibody, a buffer, an osmotic pressure regulator, a stabilizer, and a surfactant. The pharmaceutical formulation may enhance the stability of the antibody and prolongs a validity period of the antibody in aqueous formulations. Fig.8 is elected to be the abstract figure.
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