Team:Technion-Israel/Proposed Implementation
Intro
Our product, ACT., is designed to be a gel-based Over-The-Counter (OTC) product meant for skin administration. This product was created with the aim of decreasing the infectivity of SARS-CoV-2 and thereby flattening the infection curve of COVID-19.
End Users
Generally, our product was developed with the aim of providing protection for all individuals who are facing the threats of COVID-19. Therefore, there is no specific range of our potential customers since the components of our product are generally recognized as safe for all ages. However, it is worth mentioning that we won’t suggest people who have close contact with corona viruses to use ACT., due to the fact that they need to be equipped with more professional gear instead of a “civilian” protective measure.
Market
ACT. was designated to be a product that can be used by the consumers directly. For the sake of shaping the product for it to meet the customers’ desires, two surveys were published. Based on the received feedback, we decided to make ACT. as a washable cream-based product that is suitable for skin application. In order to find a more proper position for ACT. in the market, we consulted with senior executives at Dr. Fischer, one of the leading cosmetics companies in Israel, who suggested that our product will be characterized as an OTC product. Since our product might contain nickel, which is highly restricted to be used in products that come in contact with our skin by the European Union, our target market will be countries that follow the regulations published by the United States Food and Drug Administration (FDA). Therefore, to make ACT. eligible for commercialization, we were required to make sure the product can pass the review of the monograph system which regulates the parameters of OTC products, including material, dose, labeling, etc. To choose our market entry strategy, we consulted with our team PI, Professor Roee Amit, who is also one of the lecturers responsible for courses related to entrepreneurship in the faculty. He suggested that the Business-to-Business (B2B) method would probably be our best choice, which means we will sell our products to other cosmetic or pharmaceutical companies instead of reaching out to the consumers directly. The reason for applying this method is that the majority of individuals tend to choose a brand which they are more familiar with or with a great reputation. Therefore, in this way, ACT. would be able to enter the market and reach out to the public in need in a shorter period.
Future Envision
Besides flattening the infection curve of COVID-19, another driven power of ours is to make people’s lives easier by replacing plastic gloves or alcohol sanitizers with our product. If ACT. ever enters the market and becomes popular among the consumers, we believe that people will no longer suffer from the dry skin caused by over-use of hand sanitizers as well as skin allergy resulted from plastic gloves. Not only that but the reduction of plastic glove use is also likely to reduce the amount of litter caused by these single-use gloves.
If our product would be proven to be helpful in reducing the chance of getting infected by SARS-CoV-2, it could also be implemented as a rather quick response countermeasure against the next viral pandemic. The estimated time for performing screening of the Sybodies is about two weeks and the preparation of the Microgel Beads takes about a week. So theoretically, ACT. could adapt to new targets within less than a month from the moment the next novel dangerous virus is discovered.
Safety
Safety is always an indispensable part of a successful project. Due to the fact that we defined our product in the OTC category, ACT. can enter the market after implemented a monograph under the guidelines of FDA.[1] The OTC monograph provides regulation regarding type of active ingredients, indications, dose, labeling and testing. After being confirmed by the FDA that our product complies the standards listed by the monograph, it will be generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market approval.[2]
Besides the safety regulations which the product needs to meet for getting it commercially available, there are also other safety aspects which are needed to be taken into consideration in the research and development (R&D) phase. First of all, lab safety. Our team is working in the biotechnology labs which are certified as Biosafety levels 1 and 2. All of these above-mentioned labs are located inside the Technion and are equipped with all the required safety systems such as a controlled ventilating system, chemical fume hood, bio-safety cabinet, first aid kit, fire extinguisher, eye washer, etc. Secondly, personal safety. All the team members have received safety training and mandatory relevant tests at the beginning of our lab work. Moreover, wearing personal protective gear, such as gloves and lab coat, during lab work is strictly required. The third aspect is regarding biosafety of materials used for the project, including Bacillus subtilis PY79 & 168, HEK 293F cells and Saccharomyces Cerevisiae. The analysis of the possible consequences of misuse or leakage of these materials was listed on the safety page.
Future Challenges
Last but not least, according to our literature research and lab experience, there are four barriers we still need to overcome in order to make ACT. available. Firstly, our product contains the Microgel Beads with Ni+ intended to bind the His-tag tail we fused to our proteins. There is a need to consult with professional toxicologists since most of the currently existing research and regulations are targeting nickel ions instead of bound nickel. Also, according to our lab results, the yield of the Microgel is not stable and usually low, which means we need to scale up the production of ACT. to make it commercially available. On the other hand, the sporulation process resulted in a higher yield, but the cloning process is longer and more tedious than the production of the beads. Moreover, although we have already sought help from past iGEM teams that have worked with non-germinating B. subtilis strains, we got no response and hit a (temporary) dead-end on that front. Therefore, we need to find a way to obtain such a strain and implement it into our product.
- Drug Applications for Over-the-Counter (OTC) Drugs | FDA. (n.d.). Retrieved October 4, 2020, from https://www.fda.gov/drugs/types-applications/drug-applications-over-counter-otc-drugs.
- Over-the-Counter (OTC) Drug Monograph Process | FDA. (n.d.). Retrieved October 4, 2020, from https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process.
