What Are Biological Medicines?

Biological medicines are large molecules typically derived through recombinant DNA techniques from living cells and used in the treatment, diagnosis, or prevention of certain diseases.1 Some biological medicines are similar or identical to proteins and other complex substances found in the body.2

Biological medicines include therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins.1,3 These medicines are often 200 to 1,000 times the size of a small-molecule drug and are far more complex structurally.1,4

The Science of Creating a Biological Medicine Step 1: The genetic code or sequence of DNA of a chosen protein is identified. Step 2: DNA is inserted into living cells (bacteria, yeast, or cultured animal cells). Once inside, the DNA uses the cell’s machinery to transcribe and translate the DNA’s message into the biological medicine that will be used in treatment or prevention of a disease. Step 3: These genetically modified cell lines are carefully selected and cultured in increasingly larger bioreactors. Cells in the bioreactors produce the desired protein, which will become the biological medicine. Step 4: The drug is then isolated from the cells through a sequence of purification processes using sophisticated technology. Approximately 250 conditions are monitored and maintained throughout the entire process. Step 5: Formulation, fill, and finish. In final formulation of the medicine, inactive compounds may be added. The biological medicine is packaged in a sterile manner for use by doctors and patients.
Read about the differences between biological and small-molecule medicines.

Next: Biological and Small-Molecule Medicines

Biological medicines differ from small-molecule medicines in several ways. From basic size and structure to vastly different manufacturing processes, it's important to understand these differences.8,9

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

Expert Opinion

with Dr. Petricciani

“Comparing protein molecules is like comparing one snowflake to another. They may seem identical, but each biological medicine has slight variations in efficacy, safety, and side effect properties.”

Read more from Dr. Petricciani
References
  1. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28(6):1053-1058.
  2. Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2(suppl 1):i27-i36.
  3. Zhang J. Mammalian cell culture for biopharmaceutical production. In: Baltz RH, Davies JE, Demain AL, eds. Manual of Industrial Microbiology and Biotechnology, Third Edition. Washington, DC: American Society of Microbiology; 2010:157-178.
  4. Revers L, Furczon E. An introduction to biologics and biosimilars. Part I: biologics: what are they and where do they come from? Can Pharm J (Ott). 2010;143(3):134-139.
  5. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol. 2004;22(11):1393-1398.
  6. Hora M. Manufacturing fundamentals for biopharmaceuticals. In: Jameel F, Hershenson S, eds. Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals. Hoboken, NJ: John Wiley & Sons, Inc.; 2010:589-604.
  7. Webster C, Copmann T, Garnick R, et al. Biologics: can there be abbreviated applications, generics, or follow-on products? Biopharm Int. 2003(July):28-37. http://www.biopharminternational.com/biopharm/article/articleDetail.hsp?id=73785&sk=&datepageID=2 Accessed December 4, 2012.
  8. Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1(1):13-16.
  9. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1(1):1-11.