Legubixin Separation and Purification Application Case

Introduction

Legubixin is a novel anthracycline chemotherapeutic drug independently developed in China, and is a derivative of doxorubicin (also known as adriamycin). It is formed by conjugating a 6-maleimide group (EMC) with a tetrapeptide amino acid group (ALA-ALA-ASN-LEU), coupled to doxorubicin. The 6-maleimide group binds to albumin in plasma, forming a stable, non-toxic compound that reduces the drug's cardiotoxicity and damage to the immune system, while extending the drug's half-life in patients. Preclinical trials have confirmed that when Legubixin is combined with PD-1 inhibitors, the complete response rate can reach 7 times that of doxorubicin combined with PD-1 inhibitors.

Figure 1. Schematic diagram of Legubixin structure

Challenges in Legubixin Separation and Purification

Legubixin is synthesized based on doxorubicin. During the synthesis process with 6-maleimide and tetrapeptide, in addition to basic synthetic impurities, cis-trans isomers and mismatched impurities are also introduced, making separation and purification extremely difficult. Moreover, as Legubixin is a chemotherapeutic drug, unknown impurities may cause significant harm to cancer patients, so the purity requirement is extremely high, making the separation and purification of Legubixin highly challenging.

Purification Results

Based on years of experience in the purification market and advantages in chromatography resin R&D, NanoMicro has specifically developed chromatography resins suitable for the separation and purification of Legubixin. The purification process based on this resin achieves high product purity, excellent separation performance, stable process, and good reproducibility.

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Ordering Information

*This table only shows a portion of NanoMicro's normal phase silica media. For other resin requirements, please contact us.