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Search results with tag "For immunogenicity"

Guideline on Comparability after a change in the ...

Guideline on Comparability after a change in the ...

www.ema.europa.eu

• Relationship between the therapeutic protein and endogenous proteins and the severity of (potential) consequences for immunogenicity; e.g. risk of autoimmunity • Mode(s) of action: unknown or multiple modes of action complicate the evaluation of the impact of changes

  Therapeutic, Protein, Immunogenicity, Therapeutic protein, For immunogenicity

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