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Industry perspective for biotech products.

Authors
  • Möritz, A
Type
Published Article
Journal
Developments in biologicals
Publication Date
Jan 01, 2004
Volume
118
Pages
37–44
Identifiers
PMID: 15645671
Source
Medline
License
Unknown

Abstract

This presentation, held at the Joint PDA/EMEA Virus Safety Forum, provided an industry perspective on virus safety for biotech products. After discussion of the various groups of biologicals for human use, the presentation focused on a specific group of biologicals, the cell-derived rDNA products. The current authority guidelines of this group of well-defined biotech products were discussed, and a representative case study addressing virus safety aspects was presented. Questions for discussion were raised which illustrated the need for discussion between regulators and industry concerning updated guidance for this group of biologicals.

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