How Are Biological Medicines Different from Other Medications?

Small-molecule medicines are the most familiar type of medicine compounds, typically contained in a pill, tablet, or capsule.1 Examples range from analgesics and other pain relievers to antibiotics, antidepressants, and antihypertensives. These medicines are considered small molecules because their active ingredient is small in size and chemical structure.2

Biological medicines are complex products that are derived from living organisms or organic substances and include therapeutic proteins, DNA vaccines, monoclonal antibodies, and related products used for treating certain diseases. They are large molecules and are far more complex than small-molecule medicines.2-5

Small-Molecule Medicines and Biological Medicines The active ingredient has a chemical structure that is simple and small. Biological medicines can only be made in living cells. They may be thousands of times larger and far more complex. Identical copies can be made by chemists in a lab. Made in a unique living cell line; identical copies cannot be made. Small-molecule medicine manufacturing is less complex and approximately 50 simple tests and controls are required to demonstrate identity, strength, quality, potency and purity. Biological medicine manufacturing is more complex and approximately 250 sophisticated tests and controls are required to demonstrate identity, strength, quality, potency, and purity. Simple structure; can be fully characterized. Highly complex structure; difficult to fully characterize. Small-molecule medicines are generally more stable. Because they are proteins, biological medicines are highly sensitive to environmental changes. Tightly controlled conditions are required for transportation and storage. Lower potential; the molecules that comprise small-molecule medicines are so small, they can go undetected by the human immune system. Higher potential; because biological medicines are large proteins, they have the capacity to produce an immune response.
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See the high level of precision involved in creating a consistent biological product each time.

View the intricacies of manufacturing a biological medicine
Read a list of biologics questions answered by Dr. John Petricciani, M.D., an expert in biological medicines.

Expert Opinion

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References
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  10. Palomares LA, Estrada-Mondaca S, Ramirez OT. Production of recombinant proteins: challenges and solutions. In: Balbas P, Lorence A, eds. Methods in Molecular Biology, Vol. 267: Recombinant Gene Expression: Reviews and Protocols, Second Edition. Totowa, NJ: Humana Press Inc.; 2004:15-51.
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