抗体医薬品製造工程のためのハイブリッド無菌連結システムおよび無菌連結方法

Japanese Patent JP7450985

B2

The present invention relates to a hybrid aseptic connection system and aseptic connection method for a process of manufacturing an antibody pharmaceutical. In a hybrid system employing a medium storage tank made of a SS material and a bioreactor made of an SU disposable tube, to ensure a completely aseptic connection between the medium storage tank and the bioreactor, the completely aseptic connection between the medium storage tank and the bioreactor may be made by interconnection of the SU disposable tube through a welding process and the advantages of both the SS system and the SU system may be obtained at the same time. As a discharge line, an SU disposable tube and a steam trap tube are formed in a "Y" shape, the flowability in a medium transfer line may be improved and thus it is possible to prevent impurities such as a condensate from remaining in the medium transfer line, thereby preventing medium contamination in advance, and according to the present invention, complicated piping caused by the single use of a conventional SU system may be excluded, and due to the advantages of resistance to contamination compared to the single use of a conventional SS system, the economic feasibility and efficiency of the process may be secured.

Park, Chu Yang
Shin, Cha Won
Oh Tae Yang

JP2022555669A

March 18, 2024

March 08, 2021

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Prestige Biologics Company Limited

C12M1/00; C12M3/00

Merck KGaA [online],Mobius 3L Single-use Bioreactor, INTERNET ARCHIVE: WAYBACK MACHINE,公開日:2014年9月27日, [検索日:2018年10月21日],< https://web.archive.org/web/20181021032345/http://www.merckmillipore.com:80/JP/en/product/Mobius-3L-Single-use-Bioreactor,MM_NF-C84539>

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