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Protein aggregation analysis/control

The specification development process is a data-driven activity that requires a validated analytical method. The levels of data needed include assay precision, replicate process results (process precision), and real-time stability profiles. A statistical analysis of these data is critical in setting a realistic specification. Most often, aggregation and fragmentation degradation mechanisms are common to protein and peptide therapeutics. Therefore, the SE-HPLC method provides a critical quality parameter that would need to be controlled by a specification limit. [Pg.535]

See other pages where Protein aggregation analysis/control is mentioned: [Pg.408]    [Pg.257]    [Pg.398]    [Pg.401]    [Pg.402]    [Pg.479]    [Pg.535]    [Pg.2]    [Pg.74]    [Pg.260]    [Pg.272]    [Pg.77]    [Pg.209]    [Pg.251]    [Pg.285]    [Pg.744]    [Pg.745]    [Pg.141]    [Pg.254]    [Pg.111]    [Pg.886]    [Pg.284]    [Pg.287]    [Pg.141]    [Pg.76]    [Pg.330]    [Pg.59]    [Pg.379]    [Pg.398]    [Pg.405]    [Pg.224]    [Pg.2100]   
See also in sourсe #XX -- [ Pg.404 , Pg.406 ]



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Controllability analysis

Protein aggregates

Protein analysis

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