In simple words, biosimilar medicine consists in the use of microorganisms to produce a substance that we want. The microorganism that is used in this operation to recreate a substance can be a cell or a bacteria. In order to start the process of producing a biosimilar medicine, we follow the steps below:
- We identify in the DNA of a microorganism the gene that produces the substance we want to reproduce (The Science).
- The gene is extracted from the DNA and placed in a vector such as plasmids or bacteriophages.(The Science). A plasmid is a circular unit of DNA which carries the information of targeted genes (The Science). On the other hand, a bacteriophage works like a virus: They infect the bacteria in order to alter they DNA.
- The vector is used to infect the microorganism that will produce the desired substance (The Science).
- The microorganisms start producing the desired substance, or in this case, the desired medicine.
In the left picture, the above steps are summarized (click on the picture to enlarge it). The target gene is put into a vector and then transferred into a cell which will produce the desired product. Then, the cell expansion process begins. The cells produce the wanted medicine, and lastly it is extracted. The final product is purified.
In the medical industry, many microorganisms are tested in order to select the most efficient (Perez). Some bacteria may produce the medicine and save it inside of its body while other bacteria may segregate the substance. The bacteria that segregates the material is preferred since there is no need to kill the bacteria to get the substance. If the bacteria deposits the material in its body, the extraction method is to kill the microorganism in order to release the substance (Perez).
The final step to industrialize the process is to cultivate the most efficient tested microorganism. Usually, a stem cell is used to copy the microorganism. This type of cell has the ability to copy the DNA of another cell and reproduce itself. If we farm 10 stem cells that copy the DNA of the microorganism we are using, in less than a year we will have millions of microorganisms that will be able to produce the medicine we want. All the new microorganisms will have the ability of producing the target medicine.
A good example of a bacteria that produces a substance is found in the fermentation process of alcoholic drinks. The bacteria that transforms sugars into alcohol and gases suits perfectly in the production of a substance. In the medical industry, bacteria that can segregate the substance work the best.