emphasize the concept of your planning and comprehensive view in this initial summary.

clarification: in some places this assignment might be referred to as an
“outline” – the format is not an outline. That had been used
previously to emphasize the concept of your planning and comprehensive view in
this initial summary. Please do not use an outline format, it should be a
well-written paper.

In your role as directors
of the biomanufacturing department at a large U.S.-based biotechnology company,
you will be preparing plans for the production, training, and improvements
associated with manufacturing of a new protein of interest. In this group
assignment you are playing the role of the Vice President of Manufacturing for
a large biotechnology company.
Protein of interest: Avenox
– MS
Write a paper in prose (not outline) of minimum
three pages in length describing: only (4,5,6 & 7)
The 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: why
are these the most appropriate choices for manufacturing your protein of
interest? How was the expression system engineered? What is this system
The upstream and downstream processing
steps involved in manufacturing the protein [including: what facilities /
equipment are needed, what are the critical steps, how will the product be
separated and purified?]
The critical parameters in process development
and quality control [including: potential impurities, sample testing,
environmental health and safety, microbiology / biochemistry]
Regulatory compliance [including: what
regulations cover the production of this protein, e.g. FDA, USDA, EPA etc.
what special considerations need to be taken into account? What
documentation is required?]
The assignment should
be minimum 3 pages excluding figures and references and use APA
format. 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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