Biological and biochemical assays to ensure the quality and safety of plasma-derived products: Factor VIII concentrates

Miryana Radosevich, Thierry Burnouf

研究成果: 雜誌貢獻回顧型文獻

1 引文 (Scopus)

摘要

The manufacture of coagulation Factor VIII concentrates fractionated from human plasma is subjected to a set of stringent quality control tests and quality assurance procedures. These requirements apply to all stages of product development and production, from the selection and quality control of the starting plasma source material to the purification, viral inactivation, storage and distribution phases of the final product in its pharmaceutical form. The present review addresses the major in-vitro and in-vivo analytical methods important to assess the potency, quality, and safety of coagulation Factor VIII products and to detect the presence of unwanted contaminants such as proteolytic enzymes and endotoxins.
原文英語
頁(從 - 到)83-94
頁數12
期刊Current Pharmaceutical Analysis
3
發行號2
DOIs
出版狀態已發佈 - 五月 2007
對外發佈Yes

指紋

Factor VIII
Biological Assay
Quality Control
Quality control
Assays
Virus Inactivation
Plasma (human)
Plasmas
Safety
Plasma sources
Quality assurance
Endotoxins
Product development
Purification
Peptide Hydrolases
Impurities
Pharmaceutical Preparations
In Vitro Techniques

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Molecular Medicine
  • Biochemistry
  • Biophysics

引用此文

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