Design & Manufacturing

Korean Society of Die & Mold Engineering (한국금형공학회)
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Analytical comparison of structural changes of plastic cell-based therapeutic drug storage containers when exposed to cryogenic environments

플라스틱 세포치료제 보관용기의 극저온 환경 노출 시 구조적 변화에 대한 해석적 비교

  • Park, Jeong-Yeon (Molds & Dies R&B Group, Korea Institute of Industrial Technology) ;
  • Lee, Dong-Mok (Mechatronics Technology Convergence R&D Group, Korea Institute of Industrial Technology) ;
  • Lee, Jienny (Stem Cell Niche Division, CEFO Research Center) ;
  • Lee, Sun-ray ;
  • Yoon, Gil-Sang (Molds & Dies R&B Group, Korea Institute of Industrial Technology)
  • 박정연 (한국생산기술연구원 뿌리산업기술연구소 금형기술그룹) ;
  • 이동목 (한국생산기술연구원 대경지역본부 메카트로닉스융합기술그룹) ;
  • ;
  • 이순례 ((주)세포바이오 기업기술연구소) ;
  • 윤길상 (한국생산기술연구원 뿌리산업기술연구소 금형기술그룹)
  • Received : 2020.06.17
  • Accepted : 2020.06.30
  • Published : 2020.06.30
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Abstract

Recently, research and commercialization related to the field of cell-based therapeutic drug development has been actively conducted. In order to maintain cell viability and prevent contamination, refrigeration preservation devices, such as CRF (controlled rate freezer) or vapor type LN2 tanks have been developed. On the other hand, the storage container for liquid nitrogen tanks currently on sale minimizes the flow structure to prevent structural defects when stored in a liquid nitrogen tank having a high thermal conductivity than vapor nitrogen. If the cell-based treatment drug is stored in the gaseous LN2 tank as it is, the cell survival after thawing is greatly reduced. It was estimated that the existing storage container structure was a factor that prevented the rapid entry and circulation of gaseous nitrogen into the container. Therefore, this study intends to propose a new supercellular storage container model that can maintain the mechanical strength while maximizing the fluid flow structure. To this end, we estimated that the structural change of the storage container effects on the equivalent stress formed around the through-holes of them when exposed to a cryogenic environment using thermal-structural coupled field analysis. As a result of storage experiments in the gas phase tank of the cell-based therapeutic agent using the developed storage container, it was confirmed that the cell growth rate was improved from 66% to 77%, which satisfied the transportation standards of the FDA(Food and Drug Administration) cell-based therapeutic agent.

Keywords

Acknowledgement

본 연구는 한국생산기술연구원 기관주요사업(EO200070) 및 농림축산 검역본부 연구개발사업(23163047802)의 연구과제 지원에 의해 수행되었습니다.

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