It’s a pretty common routine.
You visit the doctor’s office for a medical issue and, after a brief examination, you walk out of the office with a prescription. At some point later, you stop by the pharmacy and leave with the medicine in hand.
You may not pay much more attention to the medication. After all the pill, liquid, nasal spray or injection is just something to help you feel better. But it turns out, there are huge differences in medicines. Here are the basics.
Pharmaceuticals, such as ibuprofen or aspirin, are made of chemicals that are combined, or synthesized, to create medicines. The specific ingredients are put together in an ordered process. The molecules are tiny and their chemical structure is known. It’s possible to analyze all of the components in a lab. It is also possible to change the manufacturing process, because the finished product can be tested to ensure that it is the same drug as before the change.
A biologic is, as the name implies, derived from a biological method. It is manufactured in a living system—such as a microorganism, a plant or an animal cell—and because of that, this class of medicines is much more complicated. Biologics are made of large, complex molecules or mixtures of molecules. They are usually made through what is called recombinant DNA technology. In other words, the DNA of the living system that is manufacturing the drug has been modified to produce the desired chemical.
Because the making of a biologic depends on a living system, the finished product cannot be fully analyzed in a lab. So for this class of medicines, the process of making the medicine is really the product. Pharmaceutical companies must make sure the manufacturing process remains the same time after time to ensure product quality, purity and consistency. Minor changes in the system, however inadvertent, can result in a major change to the medicine. Therefore, the makers of biologics tightly control the materials used throughout the process as well as the process itself.
Then there are generic drugs. To be approved as a generic, the drug must have the same active ingredients, strength, dosage form and method of delivery as the original medication. In other words, if the original medicine was delivered in a pill form, the generic version must be as well. It must also be a “bioequivalent.” That means the generic drug has to be the same chemically as the original drug and it has to act the same in the body. There are many patents protecting the original drugs, so usually the development of generic medicines must wait until the original patent expires.
— Frank Graff
Frank Graff is a producer/reporter with UNC-TV, focusing on North Carolina Science Now, a weekly science series that airs Wednesdays, beginning in August 2013, as part of North Carolina Now on UNC-TV. In addition to producing these special segments, Frank will provide additional information related to his stories through this North Carolina Science Now Reporter's Blog!
It’s a pretty common routine.