Method for improving aggregate removal and yield of Fc fusion protein in chromatography

• Main Authors: SHI YANG, LI ZHI, CHEN ZIJUAN, ZHUGE XIN, YU FENGCHUAN
• Format: Patent
• Language: Chinese; English
• Published: 19.03.2024
• Subjects: CHEMISTRY; METALLURGY; ORGANIC CHEMISTRY; PEPTIDES

The invention discloses a method for improving aggregate removal and yield of Fc fusion protein in chromatography, and belongs to the technical field of purification. For acidic Fc fusion protein with a PI (isoelectric point) value of about 5.0-6.0, an acetic acid buffer solution system and an acetic acid-sodium chloride-alcohol buffer solution system are used for linear gradient elution, and target protein is collected. According to the method, aggregates and small molecules can be effectively removed, HCP and potential viruses are reduced, compared with a traditional chromatographic elution method, the yield is increased by about 60%, the monomer purity is increased by about 1.2%, and the production cost is greatly saved. The method is not only suitable for laboratory scale, but also can be used as a production process. 本发明公开了一种提高Fc融合蛋白在层析中聚集体去除及收率的方法，属于纯化技术领域。对于PI(等电点)值在5.0～6.0左右的酸性Fc融合蛋白，使用醋酸缓冲液体系和醋酸-氯化钠-醇缓冲液体系，呈线性梯度洗脱，收集目标蛋白。该方法能有效去除聚集体和小分子，降低HCP以及潜在的病毒，相较于传统层析洗脱方法，收率提高了约60％，单体纯度提高约1.2％，极大的节省了生产成本。本方法不仅仅