The present invention provides a method for producing a drug product comprising a combination of highly purified collagenase I and collagenase II from Clostridium histolyticum. The method utilizes an improved medium for the cultivation of Clostridium histolyticum which includes a non-meat-derived (i.e., non-mammalian) peptone or vegetable peptone. The method includes one or more of: (1) reducing glucose content in the meat-free or vegetable-derived media; and (2) increasing the salt concentration in the meat-free or vegetable-derived media. Also provided is a drug product which includes collagenase I and collagenase II at an optimized fixed mass ratio, and which has a purity of greater than at least 95%.
本发明提供了一种生产药物产品的方法,该产品包含来自组织溶解梭菌的高纯度
胶原酶 I 和
胶原酶 II 的组合。该方法利用改良的
培养基来培养组织溶解梭菌,该
培养基包括非肉源(即非哺乳动物)
蛋白胨或植物
蛋白胨。该方法包括以下一项或多项:(1) 降低无肉
培养基或植物
培养基中的
葡萄糖含量;(2) 提高无肉
培养基或植物
培养基中的盐浓度。此外,还提供了一种药物产品,其中包括以优化的固定质量比的
胶原酶 I 和
胶原酶 II,其纯度大于至少 95%。