Biopharmaceuticals are typically made using either recombinant proteins or nucleic acids. They offer several advantages over small molecule drugs and represent a growing industry. Yet biopharmaceutical products are more susceptible to contamination than synthetically manufactured small molecule drugs. Biopharmaceutical manufacturing is derived from biological sources and often consists of four stages: production, harvest, purification and formulation/fill. As a result, they are susceptible to both biological and chemical contaminants at each step of the development process.
While bacteria, molds and yeast are more easily detected, other biological contaminants, including viruses, protozoa and mycoplasma are more challenging, as are chemical contaminants. Contaminated biopharmaceuticals impact consumer safety. Microbial contamination can also pose significant economic consequences for manufacturers and suppliers.
While maintaining current good manufacturing practices (GMPs) and ensuring quality control are good starting points, controlling contamination during biopharmaceutical product manufacturing requires methods beyond basic strategies.