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Upon reading Chapter 5 of your main textbook on "Quality Systems", please POST your answers on the Discussion board for the following 6 questions. This is assuming that you are a consultant for ABC Biologicals to develop a Quality Systems and QA unit for the manufacturing of the company's flagship monoclonal antibody product in clinical trial studies and patient care.
Your Sponsor:
The product to be developed is a monoclonal antibody. The firm, ABC Biologicals inc. is developing a proprietary monoclonal antibody to treat cutaneous T-cell lymphoma, a cancer of white blood cells. This biopharmaceutical product is a humanized monoclonal antibody that targets and bind specifically to a cell surface molecule, CD545. The molecule, developed in the laboratory, has been characterized in research and has been shown, in a transgenic mouse model, to bind to cancer cells, leading to their death. To be effective in mice, the product is given by subcutaneous injection. The firm now wishes to develop the monoclonal antibody product and apply for market approval, but will need to establish an internal Quality Systems and a QAU to manufacture the product for clinical trial uses.
Please address and POST your answers for the following questions on the Discussion section of our Blackboard.
Fill in the blanks in the “lactose absent” and “lactose present” columns in this table. (+) means significant levels of active ß-galactosidase enzyme can be detected. (–) means no significant levels of active ß-galactosidase enzyme.
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