PT  - JOURNAL ARTICLE
AU  - Stephen W. Brown
AU  - Majid Mehtali
TI  - The Avian EB66® Cell Line, Application to Vaccines, and Therapeutic Protein Production
DP  - 2010 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 419--425
VI  - 64
IP  - 5
4099  - http://journal.pda.org/content/64/5/419.short
4100  - http://journal.pda.org/content/64/5/419.full
SO  - PDA J Pharm Sci Technol2010 Sep 01; 64
AB  - Embryonated chicken eggs and primary chicken embryo fibroblasts (CEFs) have been used for decades as a means of manufacturing human and veterinary vaccines. However, these egg and CEF-based production systems are associated with many serious limitations in terms of their regulatory acceptability, production capacity, and supply chain risks. The development of a safer, cheaper, and more efficient cell substrate for vaccine production would represent a significant business advantage for vaccine manufacturers. Building on the exceptional properties of avian embryonic stem cells, Vivalis has created a new cell substrate, the Duck EB66® cell line. This article describes how this cell substrate was derived, the manufacture and qualification of a master cell bank, and the evaluation of the cell substrate for the manufacture of vaccines and human therapeutic proteins.