100mM Pro-Ac, 20 mM Arg, pH 5.0 缓冲液在生物制药中,特别是在抗体药物偶联物(ADC)的复溶和抗体储存中,主要作为优化的稳定缓冲系统应用。其标准配方通常为100 mM Pro-Ac、20 mM Arg、pH 5.0。在ADC复溶中,该缓冲液通过维持pH 5.0的酸性环境来保护连接子(如可切割连接子)的化学稳定性,减缓水解,并通过其中脯氨酸和精氨酸的协同作用(如增强水合、抑制蛋白质-蛋白质相互作用)来减少抗体聚集、控制溶液粘度并维持抗体构象。在抗体储存中,Pro-Ac缓冲液能有效增强抗体的胶体稳定性和长期储存稳定性,其含有的脯氨酸还具有天然低温保护剂特性,能在冻融过程中保护蛋白质结构。相较于传统缓冲液(如醋酸或组氨酸缓冲液),Pro-Ac在pH 5.0附近为ADC和抗体提供了更优的稳定性能。
Pro-Ac (proline acetate) buffer is mainly used as an optimized stabilizing buffer system in biopharmaceuticals, especially for the reconstitution of antibody-drug conjugates (ADCs) and the storage of antibodies. Its standard formulation is typically 100 mM Pro-Ac, 20 mM Arg, pH 5.0.In ADC reconstitution, this buffer protects the chemical stability of linkers (such as cleavable linkers) by maintaining an acidic environment at pH 5.0, slowing down hydrolysis. Through the synergistic effects of proline and arginine (e.g., enhancing hydration and inhibiting protein-protein interactions), it reduces antibody aggregation, controls solution viscosity, and preserves antibody conformation. In antibody storage, Pro-Ac buffer effectively improves the colloidal stability and long-term storage stability of antibodies. The proline contained in it also acts as a natural cryoprotectant, protecting protein structures during freeze-thaw cycles. Compared with traditional buffers (such as acetate or histidine buffers), Pro-Ac provides superior stabilization for ADCs and antibodies around pH 5.0.