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Guideline on the Validation of Viral Clearance for Plasma Derivatives

원문정보

Ho Jung Oh, Pan Soon Kim, Soon Nam Kim, Hye Na Kang, Young Lim Kim, Naery Lee, Kwan Soo Kim, Min Joo Cho, Seung Hwa Hong

한국생물공학회 한국생물공학회 학술대회 2007 춘계학술대회 및 국제심포지움 2007.04 pp.2-2
피인용수 : 0건 (자료제공 : 네이버학술정보)

초록

영어

Human blood is the source of a wide range of medicinal products, especially plasma derivatives, used for the prevention and treatment of diseases. However, the potential for blood-borne viral transmission is still considered to constitute a risk to patients. Viral removal/inactivation processes are introduced to the manufacturing process to assure the viral safety of human
blood plasma products. This guideline pertains to the validation and assessment of the viral removal/inactivation steps. It also provides the checklist for inspection of viral clearance processes.

저자정보

  • Ho Jung Oh Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration,
  • Pan Soon Kim Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration
  • Soon Nam Kim Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration
  • Hye Na Kang Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration
  • Young Lim Kim Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration
  • Naery Lee Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration
  • Kwan Soo Kim Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration,
  • Min Joo Cho Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration,
  • Seung Hwa Hong Blood Products Team, Biologics Headquarters, Korea Food and Drug Administration,

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