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 aIDress and POST your answers for the following questions on the Discussion section of our Blackboard.

1. Outline the contents of the quality manual that will serve your product’s development operation.  Cite specifically each quality system that will be included and explain why and when in development it will be applied.  Include a brief quality policy and a brief statement regarding management responsibility, as it would be approved by upper management.
2. Describe the need to design your antibody product, and explain how this will be accomplished.  Provide product-related specifics regarding quality by design and design control.
3. Review the elements of a design program specific for your antibody product, relating user needs, product attributes, and technical elements of design.  Is it possible that your product must be reworked in the research laboratory before it begins development?  Please explain the exact reason.
4. Choosing from the list of hallmarks of quality, identify what you consider to be the six most important with regard to the quality of the antibody product.  Do not choose hallmarks of design.  Explain why each was chosen and specifically elucidate how each will be applied to your product during both development and marketing phases.
5. Describe the fully functional Quality Assurance Unit, which will support the development of your antibody product and in your narrative, specifically identify the examples of how the unit will function in the areas of audit, investigations, and change control for the antibody product.
6. Describe the 5 most likely problems you will experience, as you establish quality systems and a QAU for the development of this antibody product.