Cell-therapy manufacturers are adopting workarounds for particulate testing as regulatory guidance remains unclear for products that contain cells, according to a report focused on CMC inspection practices. The article describes how manufacturers use alternate processing and testing approaches to assess visible and sub-visible particles while accounting for opaque bags and limited visual inspection options. One approach described involves running processes using formulation buffers without cells to generate particulate measurements in a clearer matrix, then extrapolating those expectations to runs that include cells. The reported particulate issues are often dominated by plastic particles introduced from single-use contact materials and equipment. Testing protocols referenced include USP chapters 790 (visible particles), 1790 (visual inspections), and 788 (sub-visible particles), alongside relevant EU visual inspection guidance for particles. The inspection rigor is also described as varying by route of administration. For developers, the operational burden and documentation strategy around particulates continues to be a key friction point as more cell-containing therapies move toward commercialization under evolving quality expectations.
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