BIOT 645 Insulin Detemir Bioprocessing and Biotechnology Paper
TOPIC: INSULIN DETEMIR
In this group assignment you are preparing a strategy report for senior management the new production process for the protein identified by your team in the Week 5 group assignment. The assignment is to work together to produce a document that will describe the company’s QA/QC strategy, operational improvement strategy, projects for disruptive improvements, international strategy and overall business strategy. For this assignment you can use a mixture of fact and fiction – the details of the report should be as realistic as possible based on your understanding of the material we have covered in this course, but you can also create your own fictitious details for anything not covered in this assignment description or in the previous assignments (e.g. plans for a therapeutic protein coming to the end of successful phase 3 clinical trials).
QA/QC Strategy – this section should deal with the company’s strategy around quality systems for the selected protein. It may include but is not limited to: details of appropriate quality standards and the company’s goals and timeline for compliance, regulatory considerations, consideration of risk management, how knowledge related to protein production will be managed, refinement of functional and impurity assays, post-market surveillance plans, company leadership oversight of QA/QC, challenges with scale-up or changes in suppliers, and lifecycle considerations.