SAFC Biosciences' product manager, John Parfet, told in-PharmaTechnologist that the Ex-Cell EBx media, which is animal component and serum free, has been optimized for EB66 and productivity without the need for microcarriers.
Parfet explained that: “Typical [viral] titer values range from 8 - 9 logs TCID50/mL when using EB66 cells grown in EX-CELL EBx expression media and infected with modified vaccina virus Ankara (MVA) in stirred tank bioreactors.”
He added that after establishing working EB66 cell banks, SAFC had screened several serum-free media (SFM), beforeselecting and scaling up the candidate that best suited the requirements of industrial production.
The EB66 line is derived from duck embryonic stem cells and is used for the commercial scale manufacture of prophylactic and therapeutic vaccines as well as recombinant proteins.
The EB66 is licensed by Vivalis to 24 pharma and biotech companies for a range of applications. Firms using the technology include GlaxoSmithKline (GSK), Schering-Plough, CSL and Sanofi-Aventis.
Pierre Miniou, director of business development at Vivalis explained that the media development project the firm originally signed with JRH Biosciences had moved into a higher gear when SAFC acquired the former in 2005.
Miniou told in-PharmaTechnologist that the: “media available on the shelves were sub-optimal for efficient cell growth and to reach high viral yield for industrial development, therefore Vivalis decided to enter into a development programme.”
He added that: “EB66 cells are fast becoming the recommended industry alternative for the safe, cost effective manufacturing of viral vaccines and recombinant proteins for human and veterinary use.”
SAFC, which will produce the media at facilities in both Europe and the US, is the sole manufacturer of the product and will work directly with biopharmaceutical and biotech companies that use the cell line on a contractual basis.