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Analyses of Amoxicillin Since the manufacturing of biopharmaceuticals is complex as they are produced within living cells such as bacterial, it may induce an immune response within the patient and can be potentially lethal. Therefore, analyses of biopharmaceuticals used must control and cover both the quality and consistency of the entire process from the raw material to the final product and the identification of any process related contaminants to meets with the submitted specifications. The objective of this report is to outline the analyses for Amoxicillin, and how analyses done on raw materials, bulk harvested product, adventitious agent, microbial contaminations and analyses of bioburden from processing equipment, air and water to ensuring the safety and efficacy of the desired product of the required drug to comply with regulatory requirements including FDA regulations and GMP standards. Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin derived from living organisms or microbial cells such as Kluyvera citrophila, Escherichia coli and Bacillus megaterium that produced in pharmaceutical industry through various stage, and it widely used to treat bacterial infection such as nose, ear, and strep throat (Charles Patrick Davis, 2015). Since the production of Amoxicillin is extremely complex as the chemical nature of raw materials and a fermentation broth are require high purification, it involves many processing steps such as purification and formulation processes to ensure safety and quality of the product. For safety, efficacy and quality manufacturing of Amoxicillin antibiotic, most pharmaceuticals and Health Canada follow the international conference on harmonization (ICH) guidelines such as Q5B-Q5D, Q3a-Q3D and M7. Analyses of Amoxicillin API production is very essential as API could inherent contaminants from product and by products during production process which may increase health risk to human. Bacteria are not inherent in the production of Amoxicillin as it introduced during establishment of culture or fermentor, cell line, downstream processing step, drug discovery and even during formulation or filling. Bioburden test or best known as microbial limit test which includes total aerobic microbial and total yeast and mold count is used to determine number of population of viable microorganisms present on or in a product. Since bacteria are likely to grow rapidly and contaminate raw materials, cell culture and purification process, the sterility assurance level (SAL) must be < 10-3 (one vial out of 1000 is contaminated at low level). The analyses of bioburden is done by visual inspection by using microscope to analyze the shape of bacterial, growth and compared it to the cell line, microbiological count which allows sores to germinates and toxin of Escherichia coli. Leachable and extractable from surface of processing equipment, reaction products could lead to acute toxicity and long term health effect which are controlled by 21 CFR 210 and 211. Analyses for raw materials including injection water must be done by using spectroscopy such as OD or NIR to ensure no variability for material that are heat, moisture or photosensitive. Content, purity and potency of the final product of Amoxicillin are analysed to control the potential of cross contamination, ensure quality and safety of product and to preserve the integrity of the product container and comply with the GMPs regulations and standards. References Shuler, Michael L., and Fikret Kargi. "Operating Considerations for Bioreactors for Suspension and Immobilized Cultures." Bioprocess Engineering: Basic Concepts. 2nd ed. Upper Saddle River, NJ: Prentice Hall, 2002. Print. "MICROBIAL BIOTECHNOLOGY - ANTIBIOTICS." Madhu Priya, 10 Oct. 2009. Web. 25 Nov. 2015. http://priyava.blogspot.ca/2009/10/microbial-biotechnology-antibiotics.html "Side Effects of Amoxil (Amoxicillin) Drug Center - RxList." RxList. Ed. Charles Patrick Davis. 2 Apr. 2015. Web. 25 Nov. 2015. <http://www.rxlist.com/amoxicillin-side-effects-drug-center.htm> "Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars" Madhu Priya, 10 Oct. 2009. Web. 25 Nov. 2015. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714370/
