Animal-free culture process for manufacture of viral vaccines: process validation and regulatory perspectives.
Pierard
I
I
GlaxoSmithKline Biologicals, Rixensart, Belgium. isabelle.pierard@gskbio.com
Mareschal
J C
JC
Gonze
M M
MM
Duchêne
M
M
D000818:Animals; D001530:Belgium; D002417:Cattle; D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards; D003470:Culture Media / Q000592:standards*; D006801:Humans; D007883:Legislation, Medical; D011506:Proteins; D015203:Reproducibility of Results; D044967:Serum; D012709:Serum Albumin; D013552:Swine; D014765:Viral Vaccines / Q000096:biosynthesis* / Q000592:standards*
D003470:Culture Media; D011506:Proteins; D012709:Serum Albumin; D014765:Viral Vaccines