Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin

A method for the reduction or inactivation of viral and microbial content in the manufacturing of pancreatin API is disclosed. The method includes treating animal-derived tissue with peracetic acid toreduce viral activity and bacterial load prior to processing. In particular, the method includes tre...

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Main Authors MANNING KENNETH S, RUF RYAN, AKULA ANISHA, Y WANG, RESTIVO JON, ROMICH MARK, NIELSEN DUSTIN, FRITZ CARMEN, CROWLEY COLIN, SPANGENBERG DANA, ANHALT KARLA
Format Patent
LanguageChinese
English
Published 27.03.2018
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Summary:A method for the reduction or inactivation of viral and microbial content in the manufacturing of pancreatin API is disclosed. The method includes treating animal-derived tissue with peracetic acid toreduce viral activity and bacterial load prior to processing. In particular, the method includes treating porcine pancreas glands with peracteic acid prior to extracting a pancreatin API from the treated glandular tissue. 公开了种在胰酶制剂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: CN201680037736