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바이오의약 및 약물전달

Strategy of Cell Culture Process Development for Proof of Concept Study

초록

영어

The biopharmaceutical industry faces increasing pressure to more rapidly develop innovative products. A potential therapeutic must face many hurdles: preclinical, manufacturing, and clinical efficacy to name a few. Method of all, therapeutic sample supply is one of initial hurdles for early phase product development. Break through challenge is to pass over the hurdles in an efficient and collaborative manner during out the beginning of development.At KITECH, we established
strategy of cell culture process development in the early stage of development. Overall our goal is supporting service to medium or small firms which develop biopharmaceutical product using delivery of their precious product of sample for proof of concept study. We present structural and strategic approach for early phase process development, without large resources using 6 sigma.

저자정보

  • Sam-Sook Sul Department of Biologics Manufacturing, Korea Biotechnology Commercialization Center
  • Yong-Hoon Chung # 2-3 Special Research Center, 198-59 Hoopyung-dong, Chuncheon City, Kangwon-do, Korea
  • Joon-Chul Lee Department of Biologics Manufacturing, Korea Biotechnology Commercialization Center

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