Transcription of Annex 3 - World Health Organization
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Annex 3 - World Health Organization
Annex 3. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks Replacement of Annex 1 of WHO Technical Report Series, No. 878. Abbreviations 81. 1. Introduction 84. 2. Historical overview 84. 3. Scope 88. 4. Definitions 89. 5. General considerations 95. Types of animal cell substrates 95. Potential risks and risk mitigation associated with biologicals produced in animal cell cultures 100. Part A. General recommendations applicable to all types of cell culture production 107. Good manufacturing practices 107. Principles of good cell culture practice 107.
use of Namalwa cells were that they contained the Epstein–Barr virus (EBV) genome integrated into the cellular DNA, and that either whole virus or DNA containing viral elements could be transmitted to the recipients of the IFN-α product. Nevertheless, by the end of the 1970s, regulatory agencies had allowed
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