Team:SHSID/Implementation
Implementation
Project Overview
To solve the problem of insufficient supply of tropane alkaloids and reduce
ecological damage, Our team fēvere factory developed genetically engineered yeast to produce putrescine,
which can be chemically modified to produce tropane alkaloids. We genetically engineered two pathways of
yeast to produce putrescine in order to enhance its efficiency and productivity. We improved the pathway
that the yeast already has by increasing the gene expression of SPE1, which is responsible for the
production of putrescine. We also inserted the AsADC and SPEB genes from oats into yeast to construct
another more efficient pathway to produce putrescine. The plasmid containing three genes was inserted into
the yeast, and its effectiveness was tested by LC-MS/MS.
Our preliminary experiment results indicate that our genetically engineered
yeast was able to significantly increase the production of putrescine compared with normal yeast. We
envision that our product could be putrescine or synthesized tropane alkaloids.
Proposed End Users
1) Pharmaceutical Firms
For pharmaceutical firms, they may be interested in collaborating with us since we will be able to provide
them with putrescine at a lower price than the market benchmark. It will lower their production costs of
tropane alkaloids and hence bring about additional profit.
pharmaceutical firms have abundant experience in handling newly-developed production methods, which may also enhance the potential success of our techniques.
pharmaceutical firms have abundant experience in handling newly-developed production methods, which may also enhance the potential success of our techniques.
2) Medical Institutions & Individual Households
For medical institutions and individual households, we may try to synthesize tropane alkaloids by the
putrescine produced by our yeast. Surely we will charge hospitals with lower prices than the market
benchmark.
Short conclusion
Our business will aim to replace competitors who supply tropane alkaloids by extracting putrescine from
plants. Thus, our price will be relatively lower compared to our competitors as our production method has
less cost of production, quicker production time, and less labor involved compared to the traditional
production method of harvesting putrescine and tropane alkaloids from plants. This essentially means that
the end-users can now enjoy a lower price, rendering our business’s offerings beneficial for those who are
in dire need of medications containing tropane alkaloids yet are not so well off.
Proposed Plan to Gain Widespread Acceptance
Putrescine production in our company is mature, and the price is fixed at $20 per gram. Synthesizing
different kinds of tropane alkaloids have different costs, so the price will be different for each kind of
tropane alkaloids. In general, our company will set the price lower than the market price of tropane
alkaloids because our putrescine production is more efficient and cheaper compared to the other tropane
alkaloid producers. Therefore, as long as fevēre factory can convince the general public that tropane
alkaloids made out of artificial putrescine will be no different from tropane alkaloids made out of
putrescine extracted from plants, it can penetrate the market easily with its low price.
Operational Plan
I. Production
As a rising pharmaceutical company that focuses heavily on research, fervēre
factory aims to decrease the cost of producing artificially-made putrescine while also increasing the production to meet market demands for pharmaceuticals containing tropane alkaloids (which are produced by synthetically combining putrescine). Therefore, the company will mainly serve as a cell factory that will combine methods tested out in the experiments, and produce putrescine using conventional methods, except that there will be modified equipment and genes that will help facilitate the process of production.
As a rising pharmaceutical company that focuses heavily on research, fervēre
factory aims to decrease the cost of producing artificially-made putrescine while also increasing the production to meet market demands for pharmaceuticals containing tropane alkaloids (which are produced by synthetically combining putrescine). Therefore, the company will mainly serve as a cell factory that will combine methods tested out in the experiments, and produce putrescine using conventional methods, except that there will be modified equipment and genes that will help facilitate the process of production.
II. Quality Control
Our company will ensure quality and efficiency in production through four quality control mechanisms:
statistical process control, lean for quality control, total productive maintenance, and 5S.
As there are several steps involved in the production of artificial putrescine, adopting a system of
statistical process control will help to ensure that quality is monitored at every step. Inspector managers
will check for errors to prevent problems from leaving the facility.
Our company will also adopt a Lean for Quality Control and Total Productive
Maintenance approach to identify improvement opportunities as well as maintain a high level of productivity.
While adopting the said quality control measures, we will also use the 5S strategy, or reusing defective
materials after detecting the problem.
Meanwhile, since our yeast is inserted with exogenous genes, which may pose a
potential risk for genetic pollution, we need to pay attention to this issue cautiously. Apart from
enforcing strictly designed lab safety rules to ensure that our gene-edited yeast did not leak from the lab,
we will also consider adding a kill switch design.
III. Location
Our company will be located at multiple venues within the Asia-Pacific, with
multiple factories and one office, which will become our headquarter in which data will be processed and
logistics will be dealt with. Due to the comparatively favorable business climate for pharmaceutical
research and development in the Asia-Pacific, fervēre factory will first settle in said region and
gradually expand to become an international firm.
IV. Legal Environment
Since PCR, CRISPR-Cas 9, and other technologies that our company uses are not
necessarily newly invented technology, legal issues do not serve as a primary concern for our future
implementation. However, we must follow the regulations and rules strictly to ensure the compliance issue of
our products.
The company will be registered as a limited company with limited liability, which makes fervēre a separate and independent business entity from its shareholders.
The company will be registered as a limited company with limited liability, which makes fervēre a separate and independent business entity from its shareholders.
V. Personnel
Employees can be divided into four major categories. As mentioned above, employees
are needed in the headquarter to work on the logistics and keep track to ensure that the company’s operation
will go smoothly. There will also be factory workers that will facilitate the production of putrescine as
well as the synthesis of tropane alkaloids. Lastly, there will be managers who will inspect the production
process and maintain a standard level of quality control (details in V. 2). The HR department will also seek
to hire professional medical researchers to do further research and experimentation on producing artificial
putrescine or other raw materials used in medications.
VI. Inventory
Most of the costs for our company are fixed costs as opposed to variable costs.
Once the genetically edited yeast is cultivated and equipment is put in place, there will be few other costs
involved in running our business.
Machinery and equipment that our company needs include but are not limited to: centrifuges, shakers, autoclaves, and plasmids.
Machinery and equipment that our company needs include but are not limited to: centrifuges, shakers, autoclaves, and plasmids.
VII. Supply Chain
Our suppliers will provide us with the equipment for genetic editing and
cultivating the genetically edited yeasts such as centrifuge, yeasts, and culture fluid. After setting up
the pieces of machinery and equipment in our factories, a constant supply of culture mediums will be needed
for the cultivation of genetically modified yeasts. fervēre factory will collaborate with suppliers and
negotiate a long-term partnership to obtain the lowest possible price, as culture mediums will be accounting
for the majority of our company’s variable cost.
For details about our implementation plan, please kindly refer to our entrepreneurship page.