Biologic therapies include wide range of medical products. Vaccines, blood products, and stem cell injections are examples of first-generation biologic therapies. However, when people talk about “biologics” they usually mean the second-generation biologic therapy drugs such as Humira, Remicade, and Enbrel.
Biologic therapies (both first and second generation) cannot be made using a simple chemical reaction, such as mixing ingredients together in a laboratory, the way conventional drugs are made. Instead, biologic therapies are made using living organisms, such as bacteria, yeast, and even mammalian tissue and cells.
Biologic drugs are made using highly complex manufacturing processes that involves living cells.
While manufacturing methods can vary, most biologics sold today to treat inflammatory joint pain are manufactured using these basic steps:
- A piece of DNA is inserted into a living cell—a yeast, bacterial, viral, or mammalian cell.
- The piece of DNA instructs the cell to produce a large amount of a specific molecule, usually a protein.
- The molecules are then isolated, so that any living cells and other material are gone and only the desired molecules are left.
- The isolated molecules become the active ingredient in a biologic drug.
The molecules in a biologic drug are different from the molecules in most other pharmaceutical products because of their large size, lack of uniformity, and weak chemical bonds:
Large size and lack of uniformity
The molecules that make up a biologic drug are not uniformly the same, and each molecule typically has tens of thousands atoms.
Weak chemical bonds
The chemical bonds that hold these molecules together are relatively weak. The molecules can degrade if they are exposed to rapid temperature changes and other factors.
Because the molecules that make up biologics are so sensitive, manufacturers must follow specific steps make and package a biologic product. Even small differences in the manufacturing and packaging process—as well as storage and administration—of a biologic can affect a drug’s ability to work.
FDA Approval of Biologics
When the FDA approves a conventional drug, it evaluates the drug’s chemical characteristics, potency and impuritiessuch as how many carbon atoms it contains. This type of evaluation cannot be done with biologics: their molecules’ variation and large sizes make it impossible for researchers to analyze and accurately describe every molecule in a biologic drug.
Because biologics are difficult to characterize, the FDA approval for a biologic drug is based on its manufacturing process. The FDA reviews the process to ensure that the end product is consistent, and there are no significant variations between one batch and another. The Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety and efficacy of the biological products.