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Overview of Cell Culture Processes
Published in Wei-Shou Hu, Cell Culture Bioprocess Engineering, 2020
The use of transgenic animals, including goats, pigs, and rabbits, for the production of biotherapeutics has been in development for three decades. Most frequently, the product protein is tissue-specifically expressed in the mammary glands for secretion into milk.43 These production systems need a low initial capital investment compared to the traditional manufacturing plant necessary for biologics. The downstream purification process is relatively simple, as the proteins are fully glycosylated. The product ATryn (antithrombin III), which was produced in transgenic goat’s milk by GTC Biotherapeutics, has been approved by the regulatory agencies in the USA and Europe.
Expression of a recombinant anti-programed cell death 1 antibody in the mammary gland of transgenic mice
Published in Preparative Biochemistry & Biotechnology, 2021
Guihua Gong, Wei Zhang, Liping Xie, Lei Xu, Shu Han, Youjia Hu
Monoclonal antibodies (mAbs) have become the fastest growing section of the pharmaceutical industry. Mammalian cell culture has become the preferred choice for the production of most commercial mAbs nowadays. However, due to limited production capacity and high costs for scale-up, these systems cannot meet the increasing demands for affordable therapeutic antibodies in clinical use. With advances in microinjection technology to modify animal genomes, the mammary gland of transgenic animals has become a new alternative for the production of recombinant proteins. In recent years, a large number of recombinant proteins and monoclonal antibodies have been successfully expressed in the milk of transgenic mice,[1] rabbits,[2] goats,[3] sheep,[4] pigs,[5] and cattle.[6] ATryn (antithrombin alpha)[7] from GTC Biotherapeutics was the first recombinant pharmaceutical, which was approved by EMA in 2007 and FDA in 2009, expressed in milk of transgenic goats.[8] Ruconest from Pharming Group NV, C1 esterase inhibitor expressed in milk of transgenic rabbits,[9] was approved by EMA in 2010 and FDA in 2014 indicating the promising future of recombinant protein production by transgenic animals.