AVENOXSUMMARY/OVERVIEW:quickclarification: in some places this assignment might be referred to as an“outline” – the format is not an outline. That had been usedpreviously to emphasize the concept of your planning and comprehensive view inthis initial summary. Please do not use an outline format, it should be awell-written paper. In your role as directorsof the biomanufacturing department at a large U.S.-based biotechnology company,you will be preparing plans for the production, training, and improvementsassociated with manufacturing of a new protein of interest. In this groupassignment you are playing the role of the Vice President of Manufacturing fora large biotechnology company. Protein of interest: Avenox– MShttps://www.ema.europa.eu/en/documents/scientific-discussion/avonex-epar-scientific-discussion_en.pdfWrite a paper in prose (not outline) of minimumthree pages in length describing: only (4,5,6 & 7)IntroductionThe business case for manufacturing the protein you have chosen[including: brief description of how will it be used, size of market,quantities needed by the market?]Your choice of model and expression system [including: whyare these the most appropriate choices for manufacturing your protein ofinterest? How was the expression system engineered? What is this systemcultured?]The upstream and downstream processingsteps involved in manufacturing the protein [including: what facilities /equipment are needed, what are the critical steps, how will the product beseparated and purified?]The critical parameters in process developmentand quality control [including: potential impurities, sample testing,environmental health and safety, microbiology / biochemistry]Regulatory compliance [including: whatregulations cover the production of this protein, e.g. FDA, USDA, EPA etc.what special considerations need to be taken into account? Whatdocumentation is required?]ConclusionThe assignment shouldbe minimum 3 pages excluding figures and references and use APAformat. It should be written in prose, not in outline format.There should be at least 5 references outside the readings for this course.
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