Introduction
It is hard to underestimate the importance of biotechnologies that are used in food and chemical production. For this assignment, the HER2 target antibody protein was chosen for analysis in order to find out how to organize the production of this new substance. To emphasize the importance of HER 2 target antibodies, it is necessary to indicate that it is widely used by many doctors all over the world in cancer treatment. According to numerous experiments, this protein is the most compatible with the organisms of human beings. Therefore, it is likely to provide normalization and is ideal to control biotherapeutic antibodies. There exists an acute need for a well-maintained and efficient HER2 target body protein production operation because if organized properly it can save the lives of countless cancer patients.
As a matter of fact, the production of HER2 target antibody protein has the potential to become a lucrative business. Hence, it should be run as one. One of the prototype factories that have already been manufacturing HER2 kits for cancer treatment is Cisbio. Currently, the company has factories and offices in France, the USA, and China. Cisbio is a leader among HER2 manufacturers. Even though proteins are among the most expensive chemicals, Cisbio has always been proud of its high degree of purification. This means that, due to the excellent quality and highly-purified ingredients of protein, it has more chances to help fight oncological issues, such as breast cancer.
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Business Case
The main application of the protein is to help patients with breast cancer as it provides the most remarkable results when fighting this decease. Several recent studied claim that HER2 should be prescribed for women with early breast cancer to reduce the risk of cancer recurrence (Quinn, 2016). In addition, previously conducted research proves that a combination of chemical and hormonal therapies can reduce such a risk. Moreover, there are researchers who have used HER2 in conjunction with chemical therapy to further reduce the risk of cancer recurrence. Owing to the HER2 usage, cancer occurs only in 50% of patients if HER2 was combined with another type of chemical therapy (Quinn, 2016).
There are many people who want to buy HER2 kits for cancer treatment but do not reside in the USA. It means that it is prohibited to import such kind of proteins to their countries even if there is a sore need to do so. A great idea for a business venture is to organize HER2 protein production and distribution, so that it will become available in many countries. In addition, there are patients who are only slightly acquainted with this protein and need more information about it.
Even though it is hard to count how many people need HER2 kits for cancer treatment, there is no doubt that this product will be successful only under the conditions of excellent quality and clearly visible results. Nevertheless, some ingredients can and should be checked in advance because some of them have an expiration period. This business case is devoted to a so-called startup to produce HER2 kits, so it is important to gradually increase production capacity. There is absolutely no need to organize the manufacturing of 10,000 kits when a company’s management does not even know how many ingredients they need and for whom their product is created. Just as with any other business, this business can be scaled only in case all business processes, including quality control, have been confirmed and there are no risks for human health (Ajithkumar, Barrett, Hatcher, & Cook, 2011).
Choice of Model and Expression System
Regarding the production model, the batch was chosen because it can manufacture chemicals in cases and provide non-stop operations. The range of production can vary from small batches to large items. The choice of model for HER2 production was founded on three factors with the first being the target audience. Second, one of the most important variables for manufacturing the protein of interest is to choose only the most high quality ingredients. Attention must be paid to the partners, counties, and suppliers which provide ingredients for production. For instance, India is notorious for providing low-fined ingredients, while the EU countries provide quality ingredients because they have higher standards for ingredient sorting and peeling (Indira, Nagaraju, & Zameer Ahmed, 2010).
According to the abovementioned information, an expression system chosen for the production will manufacture recombinant proteins. One should not forget that some proteins including HER2 can only be made in mammalian cell lines. Even though the majority of these expression vectors give low amounts of needed protein (and with higher prices), it is one of the most effective methods of protein production in standard bioprocessing (Kristoff, 2011).
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In the same fashion, the scheme of an engineered system for protein production is based on vectors that are regularly used for manufacturing cytotoxic and other kinds of protein. These kinds of vectors were chosen as they control many issues, including ions and steroid control. Moreover, it is important to control such markers and analyze bacterial control systems. The manufacturing system is aimed to monitor the inducible vectors which are established according to the modified lac operator (Kristoff, 2011).
The system is being cultivated by means of flow indirect method. This continuous process has a range of considerable advantages: a unique possibility of equipment for each stage of the process, stabilizing it in time, constant improvement of quality, ease of adjustment and, most importantly, the ability to automate. The principle of flow culturing microbes is that the vessel where microorganisms proliferate is continuously fed and uses the same volume of culture (Kristoff, 2011).
Processing Steps
Upstream and downstream processing steps involved in manufacturing the protein should be consistent and allow for no hurry. If one were to think of the physical requirements, they would ask for a well-equipped, up-to-date factory with high production capacity — up to 1000 liters of protein per day. To emphasize the equipment and facilities, the production must have a laboratory granulator to produce granules, a machine for packaging tablets with a diameter of 20-25 mm in aluminum sheet for 10-15 pieces, high-performance machines for packing in blister, a “handy” machine for filling hard gelatin capsules with powder, a mechanical manual capsule machine, a hand-packer for two-component hard gelatin capsules, and a filling machine for drums of 15-30 liters.
To be more specific, the first critical steps of protein manufacture refer to quality. The quality of incoming material as well as its cleansing is the key to “clean” protein in the final. In turn, when it comes to evaporation, which is the second stage of the process, it is critically important to control it not only by machines but by a technical specialist. Unfortunately, even 10 minutes of excess evaporation can kill any protein and prevent it from being effective for treatment. This process is also important as it is a way for HER2 protein to be separated and purified.
As for the potential impurities in HER2 protein, glucose is the only possible impurity as any other sublimations will lower the quality and the activeness of the protein itself (Kristoff, 2011) When it comes to sample testing, attention must be paid to cancer patients during all the stages of this decease. They can be offered to participate in a trial of the chemical and be clinically tested without any obligatory.
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Regulatory Compliance
When it comes to regulatory compliance, there are several governmental organizations that enforce it. First of all, there is the FDA which stands for U.S. Food and Drug Administration. This organization aims to control any food or chemical products, regulating all stages of production. The FDA can check the manufacturing process and the final outcome as well as the clinical testing. There is another relevant organization, which is the USDA, also known as the United States Department of Agriculture. This governmental organization controls the quality of ingredients and manufacturing processes. The USDA has its own rules and regulatory demands that protein production should meet. First, there should be at least two technical specialists or scientists in any company that manufactures protein. Second, even though a company can be a startup, it must have a target audience and a 30% list of pre-orders for the protein they produce. Both requirements are equally important, so any clinical tests must be tracked and account for as any of these tests may lead to a decline of health or even death. The third party that controls protein manufacturing is the EPA, which stands for the United States Environmental Protection Agency. As mentioned above, it is prohibited to operate a protein/chemical factory near any body of water. The EPA follows environmental rules and can control evaporations or any other production processes that result in HER2 protein production. In addition, any changes or alterations in the manufacturing process must be discussed with the EPA, FDA, and USDA.
There are also several documents required to produce the HER2 protein. There are three basic documents an organization must have to start such production: the Federal and State Income Tax Forms, the Product Social Security Certificate, and Documents of Determination, including a description of the manufacturing process. These documents cannot be ignored when it comes to protein production, Gathering this documentation is the first step towards protein manufacture (DeFrina, 2010).
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Conclusion
To conclude, many people are in sore need of the HER2 protein to help them fight their cancer, especially breast cancer. However, starting the production of such a protein is not easy and requires months of preparation. As for the HER2 methods of production, the flow indirect method is the best way to deliver a quality product to the patients. Moreover, the production line of HER2 should be cultivated by means of constant flow operations. Attention must be paid to documents, regulatory organizations, ingredients, and the equipment that will be used for manufacturing. In addition, it is critically important to define the target audience and export HER2 protein outside of the USA to the countries where there is a great demand for this chemical. Moreover, there are many people who need to be told about the product. It can be achieved through permission marketing.
