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Search results with tag "Therapeutic protein"
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
Guideline on immunogenicity assessment of biotechnology ...
www.ema.europa.eurelevant modules. Depending on the immunogenic potential of the therapeutic protein and the rarity of the disease, the extent of immunogenicity data before approval might be limited. Further systematic immunogenicity testing might become necessary after marketing authorization, and may be included in the risk management plan.