Mycoplasma Contaminations in the Cell Culture ... - Minerva Biolabs
Mycoplasma Contaminations in the Cell Culture ... - Minerva Biolabs
Mycoplasma Contaminations in the Cell Culture ... - Minerva Biolabs
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Instruction for Test<strong>in</strong>g<br />
• Regulations:<br />
FDA Po<strong>in</strong>ts to Consider (May 1993), Regularien 21CFR610.30<br />
USDA federal code #9CFR113.28<br />
European Pharmacopoeia 267 2.6.7, Suppl. 58 5.8<br />
ICH Guidel<strong>in</strong>e for biotechnological/biological products<br />
• Obliged to test:<br />
Master cell cultures, cell cultures, virus stocks, control cell cultures<br />
Bioproducts from cell cultures (antibodies, hormons, immune stimulators, blood<br />
products from cell cultures)<br />
Vacc<strong>in</strong>es for humans and <strong>the</strong> veter<strong>in</strong>ary field<br />
• Test necessary for:<br />
Editors who are aware of <strong>the</strong> significance of mycoplasma contam<strong>in</strong>ation
Change language