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Upstream Process of Amoxicillin Amoxicillin is one of the most widely prescribed broad-spectrum antibiotic that used to treat many different types of infections such as ear, nose and strep throat that caused by bacteria. The objective of this report is to outline the upstream process of Amoxicillin biopharmaceutical in which microbes or cells are grown to produce desired product of the required drug quality to comply with GMP regulations. Amoxicillin is a complex macromolecules that is typically derived from living organisms or microbial cells such as E-coli or Staphylococcus aureus through recombinant of DNA technology for medicinal purposes. The upstream process for Amoxicillin production is divided into four phases: working cell bank vial removed from storage of strains, selecting and improvement of strains, propagation of working bank cells in order to generate the starter cultures and cell culture. The first step in the upstream process is storing the strains in a dormant forms using standard cultures including, mixing with a sterile a spore suspension and lyophilized the spore suspension in appropriate media under liquid nitrogen which should be in a frozen state. The organism is provided with nutrients such as lactose in a concentration of 6% that it requires in the medium. Next, the medium is seeded by pellet inocula which obtained by the germination of spores and the formation of mycelia growth for two to three days, placed in incubated on a rotary shaker and supplied with oxygen. After that, the cells start to grow in large number, thawed in order to separate the cells from unique cell line and remove plasmids from bacteria cell to help in production of protein. The DNA containing the cloned gene of interest is also taken from the bacteria cell. Then, the cells is placed in seeded bioreactor to allow for multiply. The cells is transferred into production fermenter that is closely monitored and controlled in the growing phase at 24 oC with minerals content of potassium, phosphorus, magnesium, sulphur, zinc and copper and at pH range of 4.5 - 5.5. The entire upstream process may take several days or weeks to complete. References H, Schellekens. "Why Precise Manufacturing of Biological Medicines Matters." Manufacturing Matters. 2013. Web. 6 Nov. 2015. http://www.buildingbiologics.com/manufacturing-biologics.html "MICROBIAL BIOTECHNOLOGY - ANTIBIOTICS." Madhu Priya, 10 Oct. 2009. Web. 6 Nov. 2015. http://priyava.blogspot.ca/2009/10/microbial-biotechnology-antibiotics.html
