Luye Pharmaceuticals, Inc., No.9 Baoyuan Road, Laishan District, Yantai 264003, China.
School of Pharmacy, Yantai University, 30, Qingquan RD, Laishan District, Yantai 264005, China.
Eur J Pharm Sci. 2018 Mar 30;115:19-24. doi: 10.1016/j.ejps.2018.01.016. Epub 2018 Jan 9.
Charge heterogeneity is often evaluated during biosimilar development as it is a universal feature of monoclonal antibodies (mAbs). A common approach in the industry is to develop a biosimilar product with a similar overall charge profile as the reference product. However, uncertainty remains with this approach as the same charge profile in two different products may be caused by different mechanisms. In this work, we present a comprehensive investigation of the charge variants of a therapeutic monoclonal antibody and its biosimilar candidate. Not only did the candidate show a similar charge profile as the reference product, our studies revealed that the same factors contributed to the charge variants of the reference product and the biosimilar candidate. We believe our cause-based approach mitigates the risks associated with the profile-based method and is a rational approach for the charge evaluation of biosimilars.
电荷异质性在生物类似药开发过程中经常被评估，因为它是单克隆抗体（mAbs）的普遍特征。业界常用的方法是开发与参比产品具有相似整体电荷分布的生物类似药产品。然而，这种方法仍存在不确定性，因为两种不同产品中的相同电荷分布可能是由不同的机制引起的。在这项工作中，我们全面研究了一种治疗性单克隆抗体及其生物类似候选药物的电荷变异体。候选药物不仅表现出与参比产品相似的电荷分布，我们的研究还揭示了相同的因素导致了参比产品和生物类似候选药物的电荷变异体。我们相信，我们基于原因的方法减轻了基于图谱方法的风险，是生物类似药电荷评估的合理方法。
