迈百瑞站在产业前沿技术的风口
全球生物医药前沿技术与政策法规大会
2020年7月9-11日，第二届全球生物医药前沿技术与政策法规大会在苏州盛大召开，应主办方邀请，迈百瑞COO李新芳博士出席大会并作主题演讲，分享了ADC工艺优化的经验。 自2000年第一个ADC药物Mylotarg上市以来，巨大的研发成本投入、较高的临床失败风险，使得ADC药物研发的发展起起伏伏，始终处于不温不火的状态。直到2019年四个重磅 ADC产品(Polivy、Padcey、Enhertu、Sacituzumab govitecan) 的上市，沉寂许久的ADC药物迎来了爆发。
迈百瑞从2019年6月至今已经承接了4个综合性ADC项目，其中包括1个英国项目和1个韩国项目。
ADC的偶联反应是个复杂的化学过程，涉及还原温度/pH/时间、TCEP/Ab比例、抗体浓度、偶联温度/pH/时间、毒素/抗体比例、DMSO浓度等众多工艺参数，其中反应一方的抗体对温度、pH、有机溶剂又非常敏感，导致偶联过程的复杂性进一步提升。
如何通过偶联的工艺来控制ADC的关键质量参数(例如：纯度、小分子残留、DAR等) 就显得尤为关键。李博士指出，工艺即产品，一个可放大、稳定、低成本、参数易控的工艺是一个产品能否成功的根本所在。
会上，李博士还分享了二十多年的ADC研发经验，引起了业内人士的高度关注。
关于迈百瑞:
作为专业的一站式生物医药CDMO服务供应商，迈百瑞可以为全球客户提供单抗、双抗、融合蛋白、ADC等大分子药物的工艺开发、临床样品生产、商业化生产等一站式服务。迈百瑞目前拥有9条200-2000L多规模的细胞培养生产线、2条ADC原液生产线及相配套的抗体制剂生产线和ADC制剂生产线。
迈百瑞已承接了45个综合性项目，帮助客户获得了15个NMPA、6个FDA、2个TGA临床试验批件，目前有4个客户利用迈百瑞提供的样品在美国开展II期临床试验。
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