Biologics are always defined as coming from a living organism. A first-generation biologic is taken from directly from the source of a living organism, for example, human blood for donation. A second generation biologic is a biologic that is created from biotechnology.
So, how are they different from conventional drugs? Conventional medicine involves a process where two or three chemicals are combined to create the right concoction. Essentially, it’s basic chemistry, and it results in drugs being widely available commercially because this chemical process can be replicated over and over again, in a lab. Additionally, once the patent has expired on products made by major brands, lesser-known companies can imitate these drugs.
With second-generation biologics, they’re complex proteins that can’t just be replicated. However, what we do know is that every single living cell is designed to create protein. Second generation biologics involves exploiting this, through tricking other living cells to create proteins that they wouldn’t usually produce. There are a number of major cells that are used to develop biologics, and as long as they are fully functioning and alive, it’s a successful process.
There are two essential things you need to create biologics. The first is for the living cells to be able to produce an abundant amount of the desired protein. These cells also need to be maintained in an environment that encourages them to thrive. The second thing you need in biologics is a replication of the exact gene that’s responsible for creating that protein. Scientists do this by inserting the correct gene into the DNA of the host cells. They input this information into the new cell and basically instruct it to focus on producing this protein instead of what it was initially created to do.
Clearly, the entire process from locating the gene to getting a host cell to produce it naturally is incredibly complex. This is one of the biggest reasons why biologics is so expensive. From the scientists needed to the facilities and then the test subjects, there are many intricate parts to this process that means it cannot be done on a small budget.
This, of course, begs the question as to whether biologics will ever reach an affordable level – perhaps when the more prominent patents expire. The U.S. Congress also has to give the green light for this type of chemistry, in order to ensure the entire thing is regulated.