Purification process and formulation of recombinant anti rhd monoclonal antibodies

AU2025223299A1Pending Publication Date: 2026-09-10BHARAT SERUMS & VACCINES
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Patent Information

Application Number
AU2025223299
Authority / Receiving Office
AU · AU
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-02-14
Filing Date
2025-02-08
Publication Date
2026-09-10

AI Technical Summary

Technical Problem

Existing purification processes for recombinant anti-Rhesus D monoclonal antibodies face challenges in effectively removing high molecular weight (HMW) and low molecular weight (LMW) impurities, leading to suboptimal product quality and stability.

Method used

An improved purification process involving affinity chromatography, low pH inactivation, anion exchange chromatography, cation exchange chromatography, virus/nanofiltration, and ultrafiltration is employed to achieve thorough purification and enhance product quality and stability.

Benefits of technology

The process achieves a yield of at least 50% with HMW impurities less than 0.5% and LMW impurities less than 1.5%, resulting in a stable formulation with improved shelf life and compliance with international regulatory standards.

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Abstract

The present invention relates to an improved purification process for isolating anti- Rhesus D monoclonal antibodies and their antigen-binding fragments. The improved process involves a series of purification techniques, including affinity chromatography, low pH inactivation, anion exchange and cation exchange chromatography, virus / nanofiltration, ultrafiltration and the like. The present invention also encompasses a stable formulation for the purified antibodies or fragments with improved shelf life and performance of the final product.
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