Pharmaceutical or chemical testing and experimentation are restricted to human beings and animals. The tests are significant in the drug and vaccine manufacturing processes, but human and animal testing regulations restrict companies. Laboratories are forced to develop creative strategies to test chemicals and drugs before releasing them into the market. They have the freedom to use certain animals, such as lab rats and mice, for tests. Besides the lab rats, the companies are forced to consider other procedures such as these medical monoclonal production processes.
The monoclonal production process is extensive and requires advanced knowledge before embarking on scientific tests. The outcomes depend on the procedure you follow and your knowledge level. Here are some guidelines and factors you need to know about the process.
- Factors to consider during monoclonal production
The first factor is the scale. If you plan to use the procedure for individual research, the costs and the time you need may be higher. The system will also be different since you can create your process using other chemicals. Large-scale production is much easier, less costly, and requires a shorter duration since the process is standardized.
The next factor is time and monoclonal antibody production cost. The monoclonal production process can determine how competitive your company becomes. Hence you need to spend on a less costly process that consumes limited time. The most cost-friendly and time-saving approach is the commercial production process.
- The production processes
The ideal monoclonal production process involves five stages. The first stage is immunization. This process consists in immunizing the animal using the best antigens. The immunization should be offered multiple times to ensure the resulting clone is not infected by certain diseases.
The second stage is cell fusion. This process involves washing lymphocytes and mixing them with defective myeloma cells. Next, you must expose the mixed cells to polyethylene glycol for a few minutes. Polyethylene glycol is toxic; hence the longer you use it, the more toxic the mixture is. Next, you must wash the cells in a fresh medium to remove polyethylene glycol.
The third stage involves the selection of Hybridomas. The role of hybridomas is to facilitate the growth of hybridoma cells. You need to culture the cells in a HAT medium to promote the development of hybridomas cells. You also need to select only a single antibody-producing hybrid cell to improve the quality of the resulting cells.
The fourth stage involves screening the products. Before selecting the hybridomas, you must screen to ensure you only have the specific and desired antibodies. You can use two methods to screen the products: ELISA and RIA. The two methods will help you bind specific antigens and unbound antibodies and wash off the medium and other undesired components. The screening will help you identify the most potent hybridoma cells to produce needed antibodies.
The fifth stage is cloning and propagation. This process involves isolating and cloning a single antibody. You can achieve this through two main methods: limiting dilution and soft ager.
The final process is characterization and storage. During the storage, you need to observe the storage guidelines to ensure the stability of the cells. In storage, the cells must withstand freezing and thawing. You can use liquid nitrogen to achieve effective results.
- Challenges during the monoclonal production process
There are various challenges that may make the above procedure inefficient, costly, and time-consuming. These challenges include ethical concerns. For instance, human cells cannot be cloned for ethical considerations, and their cells cannot be immunized against antigens.
Sometimes the myeloma cells in test animals such as mice are volatile and may require additional processes to be stable. The test can also not be conducted on a human since there are no human myeloma cells that can be easily replaced by cells from a mouse. These reasons can also hinder large-scale production processes.
- Large-scale production processes and their significance
You need to consider resources and time to limit the chances of errors occurring. The process has to be standardized and procedural to avoid the side effects. Commercial operation is necessary for significant reasons. It can produce cells for diagnostics, preventing harmful diagnostic procedures from being carried on live animals. It can also be used for therapeutic needs to generate cells and see their response to certain conditions.
Due to the level of regulations in the therapy industry, the only beneficial procedure is to rely on cloned cells. The diagnostic sectors rely on the monoclonal production process to speed up the production of various drugs and vaccines.
- Effective commercial monoclonal production processes
The commercial production process may differ from the small-scale process due to technology. There are also various methods to avoid developing a new procedure. The two main methods for commercial monoclonal production include In Vivo and In Vitro Methods. However, the In Vivo process tends to be less costly than the In Vitro method. The procedures and components applied in the two ways also vary widely; however, the results are similar.
Conclusion
During the process, you must observe regulatory guidelines since violating these guidelines could lead to high penalties and severe consequences. The method and procedure will depend on your project’s scale and the desired results. You also need to observe the process to ensure quality results.
