The issue of laboratory animal reduction has gradually been noticed, and countries worldwide have launched some plans to tackle it. Following this trend, we decide to improve hybridoma technology to keep the advantage of animal-derived animals and optimize the antibodies while reducing animal use in experiments.
The application method, advantages, disadvantages, and method to manage risks of our technology will be elaborated as follows to help our target users understand our technology better. Meanwhile, we provided any audience who may be interested in our technology with future aspirations. After reading this short introduction to the usage of our project, we hope that we can reassure our target users about any safety issues concerned.
The target users of our technology are biotechnology companies aiming at producing and selling monoclonal antibodies. Under the trend of laboratory animal reduction, several biotechnology companies have started to implement non-animal derived methods to produce monoclonal antibodies. However, as the experts we interviewed informed, the affinity and specificity of antibodies are the primary factors that influence researchers and medical staff when choosing, and there is still ample space for improvement regarding non-animal derived antibodies.
Fortunately, our project aims to reduce animal use in the production of mAbs while retaining the advantages of animal-derived antibodies. In addition, it is possible that if keeping on researching, this method can hopefully produce mAbs against different variants without sacrificing laboratory mice. For biotechnology companies, if they can use this technology, they can broaden their market reach by providing mAbs with higher quality. Also, they can discharge social responsibilities and improve their cooperate image. Therefore, we are deeply convinced that our project can do good for the target biotechnology companies.
A detailed explanation of the usage of our technology can be found in our experiment protocol (For more information,please see the Experiments page). Following is a brief outline of the steps needed for the usage of our technology:
Our bioreactor aims for suspension-cultured cells, such as Chinese hamster ovary cells(CHO cells) or Human embryonic kidney cells(HEK cells), which can mass express recombinant antibodies.
To compare the advantages and disadvantages of our technology, we use the PEST analysis method and SWOT analysis. PEST analysis ( for Political, Economic, Social, and Technological) is a tool for evaluating four external environmental factors. Companies can be identified, understood, and analyzed for optimal planning by understanding each PEST factor. SWOT analysis( for Strength, Weak, Opportunity, and Threat), which is often used to analyze internal and external factors in business, to help us assess our program's strengths, weaknesses, opportunities, and threats by focusing on our strengths, minimizing threats, and making the most of any possible chance.
Through PEST analysis, we found that in terms of policy, the National Laboratory Animal 3R Center has been set up to follow up on the trend of reducing the number of laboratory animals. In the interview with Ph.D. Su and Ph.D. Chen from National Laboratory Animal Center, we confirmed that our plan aligns with the domestic policy on laboratory animals. In addition, we plan to look forward to reducing the cost of purchasing laboratory animals and producing monoclonal antibodies in less time. Socially, after our interview with the CEO of the Taiwan Animal Society Research Association, we confirmed that our plan is helpful and can provide researchers and biotechnology companies with feasible animal reduction experimental methods.
Through SWOT analysis, we found that the strength of our plan is in line with the international trend of laboratory animal reduction and can optimize the mAbs production of Hybridoma technology. Although there are still uncertainties in antibody quality control and random mutation in our project, some new methods of making monoclonal antibodies have emerged.Our plan challenges the existing business model but we obtained positive feedback from experts.We believe it can provide biotechnology companies and researchers with technologies that align with laboratory animal reduction.
Our users need to insert a recombinant vector into our hybridoma cells to induce mutation inside them. The hybridoma cells will thus be capable of producing monoclonal antibodies with higher affinity against the original antigen or even variant types of antigen. The organisms we recommend are recombinant lentivirus and hybridoma cell lines that our users require. There will be some lurking safety concerns when the experiments are carried out. To make sure our project is safe and responsible for the environment, we have done an evaluation bellowed:
The entire process of the experiment should be carried out at a lab that sticks to the regulation. Also, users are recommended to do thorough research on the target antigen if one may do harm to human beings or the environment and obey the operations throughout the experiment.
If the lentivirus is accidentally spread out of the lab, it may cause the cell or the infected organism to express the gene it carries. However, the sequences responsible for viral reproduction and the sequences that may cause cellular toxicity have already been removed from the original genome of the virus after the transduction. As a result, once every transduction procedure is carried out under the regulation of the BSL 2 laboratory, the probability of the autonomous spread of the virus is nearly zero. In summary, the virus is unlikely to infect cells in a natural environment and rarely reproduces in a non-laboratory environment. With all laboratory facilities following the regulation of BSL2, the chance of the virus spreading and causing unexpected safety concerns are rare.
Since our initial preparation, we searched in our institute and country regulations to guarantee that our plan indeed complies with the laws in local areas. The equipment and protocol involved in our experiment or technique are also thoroughly evaluated by us at an early stage. We got the information from paper research and then discussed it with our instructors or advisors. Through these efforts, we ensure that our project can surely do more good to the world than harm as long as the experiments are conducted under all regulations.
Our technology is currently aiming at optimizing the affinity of the antibodies. The mechanism of Activation-induced cytidine deaminase(AID) is to mutate the gene of hybridoma cells and cause the construct conversion of the outcoming monoclonal antibodies. Therefore, if we can keep on digging in, there is the possibility that we can produce mAbs against different virus variants to respond to epidemics like COVID-19 rapidly. Also, we want to add a computer automatic control system to our bioreactor and provide our target users with a more convenient method to mass produce antibodies.
