BUFFER PREPARATION AND TRANSFER SYSTEM FOR ANTIBODY DRUG MANUFACTURING PROCESS

Title:

BUFFER PREPARATION AND TRANSFER SYSTEM FOR ANTIBODY DRUG MANUFACTURING PROCESS

Document Type and Number:

WIPO Patent Application WO/2021/194128

Kind Code:

A1

Abstract:

The present invention relates to a buffer preparation and transfer system for an antibody drug manufacturing process, in which the preparation and transfer of various buffer solutions are automated using a control unit, and configurations of an apparatus are arranged and designed such that a concentrated component solution is transferred into a buffer storage tank via an opening/closing valve and a flow rate control valve to control the concentration and composition of a buffer, thus reducing a lot of labor input according to individual buffer preparations, such as weighing a buffer chemical, adding powder, stirring, and transferring, and allowing the manufacturing time to be significantly shortened, and, unlike the prior art, it is also advantageous in terms of securing a safe distance between steps and securing the area of a facility, due to the reduced number of buffer preparation tanks corresponding to individual buffer storage tanks, and the safety of a worker can be ensured due to the automated system. Moreover, in the buffer preparation and transfer system according to the present invention, a buffer preparation tank and a concentrated component tank are provided as a single-use (SU) bag material, and thus concerns over corrosion (metal corrosion due to acid, or the like) according to the use of a highly concentrated buffer solution are minimized, and separate washing and sterilization steps can be omitted, thus further shortening the manufacturing time, and it is greatly advantageous in that, as compared to the prior art, the quality of buffer is uniform and buffer solutions can be prepared according to desired recipes.

Inventors:

PARK JOO YANG (KR)
SHIN JA WON (KR)
OH DAE YANG (KR)

Application Number:

PCT/KR2021/002839

Publication Date:

September 30, 2021

Filing Date:

March 08, 2021

Export Citation:

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Assignee:

PRESTIGE BIOLOGICS CO LTD (KR)

International Classes:

C12M1/34; C12M1/00; C12M1/36

Domestic Patent References:

WO2019158906A1

2019-08-22

Foreign References:

KR20190037288A	2019-04-05
US4116046A	1978-09-26
US20130164400A1	2013-06-27
CN104906144A	2015-09-16

Other References: