ASTM E3060-16

1.1 Biotherapeutic drugs and vaccines are susceptible to inherent protein aggregate formation which may change over the product shelf life. Intrinsic particles, including excipients, silicone oil, and other particles from the process, container/closures, equipment or delivery devices, and extrinsic particles which originate from sources outside of the contained process, may also be present. Monitoring and identifying the source of the subvisible particles throughout the product life cycle (from initial characterization and formulation through finished product expiry) can optimize product development, process design, improve process control, improve the manufacturing process, and ensure lot-to-lot consistency.