As we have seen from earlier assignments, the choices made in the bioprocessing pipeline are critical to the commercial success of a bioproduct. From the choice of expression system and its growth conditions, though how biomolecules are harvested, purified and concentrated there are many variables that can influence the costs, risks and profitability of bioproduction.
The biomanufacturing marketplace can be quite dynamic, with the costs and profits associated with a product changing rapidly. In this assignment we will delve into the business of producing a specific product, considering rival products, production methods as well as opportunities for expanding markets.
Week 10 Details
For this assignment, you have been tasked to draft a business plan for the company that is sponsoring the therapy that you identified in Week 7 (for treating COVID-19). Write a concise report of short answers clearly answering the questions below related to this business plan (limited in total to a maximum of 750 words):
Introduction: Briefly summarize the product, its stage of development, the company manufacturing the therapy and the indication that the therapy will be used to treat.
Intellectual Property: In order to market your product, your company will likely need, already have, or to license at least one appropriate technology. Identify and describe one current, relevant US issued patent relevant for producing your product. If you need to license the technology (i.e. your company is not already the assignee) describe how your company will try to license the technology.
Regulatory Strategy: What is the regulatory approval strategy your company is pursuing? How much time, money and effort is required for your product to complete clinical trials? Please provide specific dates, cost estimates and information on challenges or strategies your company may face in the U.S., EU or other countries as it seeks regulatory approval and any approaches the company may take once the therapy is on the market.
Bioproduction Strategy: From the process you described in Week 7 and information available on comparable products, what are the estimated costs of production? What are the major variables that will influence the cost of production? Are there particular considerations the company should consider in scale-up for when the product hits the market?
Marketing: What is your target market for this product? Who are the major customers? Where are they located? What is the size of market? What would be a reasonable selling price for your product and why?
Competitors: What similar products are already available or being developed for the same indication? Who manufactures them? Where are they located? How much do they sell for?
SWOT Analysis: Summarize your findings in a SWOT analysis matrix.
If you are not familiar with a SWOT analysis, here are some resources describing what it is and what to include:
https://extension.psu.edu/conducting-a-swot-analysis
https://ctb.ku.edu/en/table-of-contents/assessment/assessing-community-needs-and-resources/swot-analysis/main
https://www.mindtools.com/pages/article/newTMC_05.htm
Grading Details
What: 1 Biomanufacturing assignment posted in your Assignments Folder. The assignment should be no more than 750 words and use APA format. There should be at least 5 references outside the readings for this course.
Percentage of Final Grade: 10%
Grading Rubric & Late Policy: Assignment Rubric (under Content)
Due Date: By end of Week 10
Last Completed Projects
| topic title | academic level | Writer | delivered |
|---|