Microbiological Considerations of Biotechnology Products

The selection of a sterilization strategy for a drug product that requires aseptic manufacturing is generally determined by the stability of the drug substance. For stable products, terminal sterilization, including heat sterilization or exposure to radiation or chemicals such as ethylene oxide or vaporous hydrogen peroxide, is the preferred strategy. However, most biologic drugs are unstable when exposed to heat, radiation, or chemicals and generally require aseptic manufacturing using sterile filtration. Successful sterile filtration requires a drug product formulation with an appropriate viscosity and compatibility with the contact surfaces and shear stresses involved in pumping the fluid. Single-use technology is widely used in sterile fill/finish operations today, reducing the turnover time and cross-contamination risk.

Most biologic drugs are unstable when exposed to heat, radiation, or chemicals and generally require aseptic manufacturing. Several elements are to be considered for aseptic processing, the environment, the equipment, the operator, and the air quality. Specifications for each of these elements are illustrated, followed by the application of laminar flow hood and biological safety cabinet. Viral decontamination of biologics is a quality control of paramount importance since many biologics are derived from microbiological sources involving virus or bacteria.