The question of whether biologics are made from stem cells represents a common confusion between two of the most advanced areas of medical science. Both biologics and stem cell therapies involve sophisticated techniques rooted in biotechnology, leading many people to assume they are the same. Clarifying the fundamental difference in what each product is—a complex molecule versus a living cell—is necessary to understand their distinct roles in modern medicine.
What Biologics Are and How They Are Classified
Biologics are a diverse group of medical products derived from, or produced by, living organisms. Unlike conventional small-molecule drugs, such as aspirin, biologics are typically large, complex molecules, often including proteins, sugars, or nucleic acids. The manufacturing process involves using genetically engineered cells, such as bacteria, yeast, or mammalian cells, as “biological factories” to produce the desired therapeutic substance. Examples include vaccines, blood products, therapeutic proteins like insulin, and monoclonal antibodies used to treat cancer and autoimmune disorders.
Understanding Stem Cells and Their Therapeutic Use
Stem cells are unique cells characterized by two main properties: the ability to self-renew and the potential to differentiate into many specialized cell types. These cells function as an internal repair system, generating replacements for cells lost due to injury or disease. Primary types include embryonic stem cells, which can become any cell type, and adult (somatic) stem cells, which are found in specific tissues and generally only produce the cell types of that tissue. Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed in the lab to mimic the versatile properties of embryonic stem cells. Stem cell therapy, or regenerative medicine, uses these living cells to repair or replace damaged tissue, such as using hematopoietic stem cells in bone marrow transplants.
The Manufacturing Divide: Products vs. Living Cells
The core distinction between biologics and stem cell therapies lies in the nature of the final therapeutic agent. A biologic is a purified product—a complex protein or molecule—that is produced by a living system, but the host cell used in its creation is discarded before administration. Conversely, a stem cell therapy is the living cell itself, which serves as the therapeutic agent once infused into the patient. Manufacturing a biologic involves growing engineered host cells (like yeast or Chinese Hamster Ovary (CHO) cells) in large bioreactors to mass-produce the therapeutic protein, which is subsequently isolated and purified. Cell therapies, however, require specialized facilities to harvest, process, and multiply viable stem cells, ensuring a precise dose of functional cells is delivered to perform their regenerative function within the patient’s body.
When Stem Cell Research Informs Biologic Development
While stem cells are not used to manufacture traditional biologic drugs, the two fields frequently overlap in research and development. Stem cells, particularly iPSCs, are widely used in drug discovery as sophisticated disease models to test the efficacy and safety of new drug candidates. Researchers differentiate patient-derived iPSCs into specific cell types, such as heart muscle or neurons, that carry a disease-causing mutation. These disease-specific cells are then used to screen thousands of potential biologic drugs, providing a highly relevant human cell environment for testing. Furthermore, the specialized growth factors and signaling molecules necessary to guide stem cell differentiation are themselves a class of biologics.