Method for reducing or inactivating viral and microbial contents in manufacturing of pancreatin

A method of reducing or inactivating viral and microbial contents in the manufacture of pancreatin preparation APIs is disclosed. The method comprises treating animal-derived tissue with peracetic acid to reduce viral activity and bacterial loading prior to processing. In particular, the method comp...

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Main Authors NELSON DANIEL, WANG YUANXUN, MANNING KENNETH S, AKULA ANISHA, RUF ROLAND, RESTIVO JON, ROMICH MARK, FRITZ CARMEN, SPANGENBERG DANA, CROWLEY CHRISTOPHER, ANHALT KARLA
Format Patent
LanguageChinese
English
Published 07.12.2021
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Summary:A method of reducing or inactivating viral and microbial contents in the manufacture of pancreatin preparation APIs is disclosed. The method comprises treating animal-derived tissue with peracetic acid to reduce viral activity and bacterial loading prior to processing. In particular, the method comprises treating the porcine pancreas with peracetic acid prior to extracting the pancreatin preparation API from the treated gland tissue. 公开了一种在胰酶制剂API制造中减少或灭活病毒和微生物内容物的方法。该方法包括用过乙酸处理动物衍生的组织,以在加工之前减少病毒活性和细菌载量。具体地说,该方法包括从经处理的腺体组织中提取胰酶制剂API之前用过乙酸处理猪胰腺。
Bibliography:Application Number: CN202111036858