interferon β biosimilar / Amneal - LARVOL DELTA

Cell based assay identifies TLR2 and TLR4 stimulating impurities in Interferon beta. (PubMed, Sci Rep) - "...This study, showed that Betaseron and Extavia, which are reported to be more immunogenic among IFNβ products in clinical usage, contain residual innate immune response modulating impurities (IIRMIs) capable of activating NF-κB and induced expression of inflammatory mediators. These IIRMIs were undetectable in Rebif or Avonex...Together these data suggest that cell based assays can reveal subtle but clinically relevant differences in IIRMIs following manufacturing changes or between products with the same active ingredients but different manufacturing processes. Appreciating these differences may inform immunogenicity risk assessments."

Journal • Preclinical