SpeakerDr. Linda Narhi, Scientific Executive Director at Amgen, Host: Dennis Clegg
Date and LocationWednesday March 09, 2016 11:00am to 12:00pm
The goal of protein therapeutic development is the production of a drug that is safe and efficacious. This means understanding what the critical quality attributes (CQA) are; what modifications and degradants need to be controlled and which have no effect on safety or efficacy of the protein . Protein aggregates have the potential to be a CQA, as they could be immunogenic or differ in potency relative to the monomer. In this talk I’ll describe studies we’ve done at Amgen to determine the relative risk of immunogenicity of different types of protein aggregates in the 50 nm to 10 micrometer size range. This included using different types of stress to generate protein aggregates, characterizing the aggregates, and testing them in in vitro and in vivo model systems. The results of these studies suggest that the size, amount of chemical modification, conformation, and dosage all play a role in the relative immunogenicity of protein aggregate, and that in vivo the immune response is weak and transient.