Making medicine is complex: it requires high levels of precision, controlled environments and specialist scientific expertise.
Making biologic medicines is a particularly complex process, involving an exponential number of steps that starts with genetically engineering living cells.
Using state-of-the art lab equipment, highly-skilled scientists create a strand of DNA that provides precise instructions to these cells to make the biologic medicine — usually a complex protein.
When placed in the right environment, these changed living cells, called the cell line, will start to produce the protein required to make a biologic medicine.
But, in order to get enough of the protein to make a biologic medicine, the cell line needs to be cloned and cultivated in vast numbers in very precise conditions. Variations in temperature or acidity, for example, can change the way the cells behave, which in turn could change the characteristics of the protein in a way that might impact the medicine itself.
If the right conditions are not kept throughout the manufacturing process, the characteristics can change, potentially destroying the protein structure. So, intense monitoring and testing is carried out throughout the manufacturing process to make sure the correct protein characteristics are maintained, and that quality, tolerability and efficacy is validated from batch to batch.
Using genetically-engineered living cells to create medicines is a complex undertaking that has been the result of technological and scientific progress, and there is still potential for future treatments. As researchers learn more about diseases and how they manifest within the body, and as technology continues to progress, biologic medicines will continue to be engineered to treat an even wider range of diseases.
Watch to understand how DNA is engineered for biologic medicines.