Culture Media
For the small scale virus removal studies, including validation studies according to guidance (EMEA, 1996), fermenter feed media used for the manufacture of a biopharmaceutical product was used. The media consists of DMEM / HAMS F12 to which Ethanolamine, Poloxamer 188, Soy Peptone, L-Glutamine, NaHCO3 and Copper were added. The pH of the media was initially adjusted to 7.2 to 7.6. Soy-peptone (as animal-derived material free nutrient) was added in different concentrations and from different manufacturers.
In order to avoid bacterial contamination during the virus filtration experiments, antibiotics (Gentamicin 0.1 g/L and optionally Penicillin 90 U/L with Streptomycin 0.1 g/L) were added to the un-spiked media.