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Critical Quality Attributes Classification
| Product-Related Attributes- Comparative Testing | Process-Related Attributes- Release Specification |
|---|---|
| Primary, secondary, tertiary, quaternary structure, post-translational modifications, forced-stability testing, physicochemical and biological properties. | Protein content, potency, impurities, aggregates, sub-visible particles, physical properties [if the formulation is the same], sterility, host-DNA, and shelf-life testing. |
