Continuous and semi-continuous cell culture for production of blood clotting factors.
Recombinant clotting factors are important biotherapeutics that Pfizer has produced and marketed for over fifteen years. Owing to the complexity of the structure and function of these blood factors, it can be challenging to achieve the required product quality and manufacturing productivity. The article highlights the semi-continuous and continuous cell culture processes employed by Pfizer for the production of BeneFIX and ReFacto AF. The benefits of such processes, the challenges of maintaining an aseptic production culture for extended periods, and batch definition are discussed in this article.
Manufacturing Sciences and Technology, Pfizer, One Burtt Road, Andover, MA 01810, USA. Electronic address: sunil.desai@pfizer.com.
Sunil G
SG
Desai
D000818:Animals; D019149:Bioreactors; D016466:CHO Cells; D018929:Cell Culture Techniques; D003412:Cricetulus; D005164:Factor IX / Q000096:biosynthesis*; D005169:Factor VIII / Q000096:biosynthesis*
C427184:recombinant factor VIII SQ; D005169:Factor VIII; D005164:Factor IX
BeneFIX; Blood clotting factors; Continuous bioprocessing; Factor IX, factor VIII; Gamma-carboxylation; Perfusion; Post-translational modifications; Re-feed; ReFacto; ReFacto AF; Semi-continuous bioprocessing; Xyntha