Many consumers have misconceptions about the difference between prescription drugs and biologics, although many people may one day be treated with a biologic medication at some point. Biologics have revolutionized the treatment of chronic diseases like multiple sclerosis, rheumatoid arthritis, and Chrohn's disease and they are even used to treat many types of cancer. Here's how biologics are made and what makes them unique.
What Are Biologics?
Biologics are medical products usually made from a natural source and manufactured in a living setting, such as a plant or animal cell. Biologics are usually very complex molecules or mixtures of molecules that may be made with recombinant DNA technology, which involves joining together DNA molecules from different species into a single host organism.
Biologics have been around for many years, although first-generation biologics were obtained wholly from animals and humans such as insulin from pigs, influenza vaccines made from viruses grown in chicken eggs, and human blood. Newer biologics rely on complex biotechnology for manufacturing.
Well-known examples of biologics include:
- Human tissue and cells like tendons used for transplantation
- Gene therapy
- Tests to screen blood donors for infectious disease
- Allergenic extracts used to treat or diagnose. This includes allergy shots
The process of making biologics involves tricking cells into producing different and complex proteins for medical use. To make a biologic, there must be living cells that can be grown in very large quantities and maintained under perfect conditions to allow them to function normally. Because cellular instructions for making proteins are carried in a cell's DNA in the genes, researchers must then isolate or create the correct gene to tell the cell how to produce the right protein. Beginning with the normal cell, the new gene is inserted into the DNA where it becomes permanent. The cell will now produce the specific protein like a factory. This complexity is party of why biologics are more expensive than drugs. Another factor in the cost of biologics is the fact that the number of people who are treated with the products is usually somewhat small compared to the number of people who can be treated for common disorders with drugs.
How Do Biologics Differ from Drugs?
Many biologics are used to treat medical conditions and disease, just like drugs. One primary difference is many biologics can also be used to prevent or diagnose disease. For example, biologics can include vaccines, gene therapy, allergy shots, and tests to screen blood donors.
Drugs and biologics are also manufactured very differently. While biologics are made from natural sources in a living setting like a microorganism, drugs are usually manufactured through chemical synthesis, or synthesizing new chemicals from other chemicals. A drug usually has a very specific chemical structure and the final product can be analyzed to determine its components. A complex biologic, on the other hand, can be nearly impossible to "unravel" using laboratory methods and some components may be unknown.
As the product is really the process with biologics, it's important to ensure the manufacturing process remains the same in terms of purity, quality, and consistency to ensure the final product is the same. Because biologics use living systems, manufacturers must carefully control the nature and source of their starting materials because even tiny differences can dramatically affect the way biologics behave in the body. Drug manufacturing can be changed a great deal because the final product can be tested to ensure it's identical.
Put more simply, biologics are complex proteins that cannot be made with a chemical recipe like drugs. Biologics are really just complex proteins that work by taking advantage of the fact that all living cells know how to make proteins. The process of manufacturing biologics "tricks" cells into making proteins with biotechnology. Depending on the biologic, cells that may be used for manufacturing include bacteria (like E. coli), yeast, and CHO, which originally came from a Chinese hamster.
The Future of Biologics
There are currently more than 200 biologics on the market with hundreds more in various stages of clinical testing and regulatory approval. Biologics are predicted to account for about 17% of total global medicine spending by 2017 and 7 of the top 10 global medicines by spending. Over the past decade, the biologics industry has grown rapidly with new types of molecules, improved delivery methods, and better instruments for characterizing proteins. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), biopharmaceutical companies in the U.S. are already using biological processes to develop more than 900 vaccines and medicines to target over 100 diseases, including more than 400 cancer therapies, over 100 vaccines for infectious diseases, more than 70 medicines for autoimmune diseases like rheumatoid arthritis and lupus, and almost 60 treatments for cardiovascular disease.
The new generation of biologic medicine is still in its infancy but has already shown great promise for revolutionizing medicine. The biopharmaceutical research sector is expected to remain at the forefront of developing new treatments for some of the most challenging and costly diseases to treat.