Safety assessment of Madin Darby canine kidney cells as vaccine substrate.
Conventional influenza vaccines are manufactured using embryonated chicken eggs, a substrate with little flexibility and vulnerable to extraneous agents. Solvay Pharmaceuticals developed a production technology based on the continuous cell line Madin Darby Canine Kidney (MDCK) as vaccine cell substrate. A risk-based safety assessment of MDCK, with respect to tumorigenicity of intact cells and oncogenicity of cellular components, cellular DNA and adventitious agents, shows that this substrate is as safe as other substrates and therefore without increased risk to the vaccine recipient.
Solvay Pharmaceuticals BV, Weesp, The Netherlands. jeroen.medema@solvay.com
J K
JK
Medema
J
J
Meijer
A J
AJ
Kersten
R
R
Horton
D000818:Animals; D018929:Cell Culture Techniques / Q000592:standards*; D002460:Cell Line; D002470:Cell Survival; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification; D004285:Dogs; D005260:Female; D006801:Humans; D011785:Quality Assurance, Health Care; D012449:Safety; D014612:Vaccines; D014780:Viruses / Q000235:genetics / Q000302:isolation & purification* / Q000472:pathogenicity
D004279:DNA, Viral; D014612:Vaccines