Biologics or Biological Products – Beyond Pharma
Unlike most drugs that contain chemical substances with known structure and purity, biological products are made or derived from biological sources, such as cells, tissues or plasma from humans, animals or microorganisms. Often biological products are complex mixtures that cannot be characterized fully by physico-chemical methods, routinely used to characterize most drugs. Biological or therapeutic activity (safety and potency) of biological products is measured by bioassays using biological systems, such as animals, tissues, and microorganisms. Therefore, most of the tests for safety and potency have large inherent variability due to biological nature of the product itself as well as variability of biological methods used to test these products.
Further, biological products differ from conventional drugs in that these are often heat-sensitive and susceptible to microbial contamination during the manufacturing process and at the final dosage form. This is because media components used during manufacture of these products, and biological products themselves, being proteins, carbohydrates or enzymes, support microbial growth. Therefore, sterile processes are employed from initial manufacturing steps with sterility testing performed at various stages during manufacture. Additionally, starting materials used in the manufacture of these products are often of biological origin, such as viruses, bacteria and cells that may already have inherent and extraneous or adventitious microbial contaminants. Thus, extensive testing is essential throughout manufacture of biological products.
