News Feature | March 27, 2014

BioOutsource Announces Launch Of Flagship Bioassay

By Estel Grace Masangkay

BioOutsource announced that it is launching the flagship Reverse Signaling Apoptosis Bioassay, a requirement for the licensure of Humira and Remicade BioSimilars. BioOutsource is a company offering biologics contract testing and BioSimilar characterization for the biopharmaceutical industry.

Dr Daniel Galbraith, BioOutsource Chief Scientific Officer, said, “We are delighted to be the first to bring the Reverse Signaling Apoptosis Assay to market. It completes our extensive range of characterization testing capabilities and ensures BioOutsource now support(s) the full biological characterization of Humira and Remicade BioSimilars.”

Humira and Remicade biosimilars are monoclonal antibodies developed by BioOutsource for the treatment of autoimmune diseases. Humira (Adalimumab) is a fully humanised monoclonal antibody and has won approval for the treatment of severe rheumatoid arthritis, ankolysing sponglylitis and Crohn’s disease, among others. Remicade (infliximab) is a chimeric monoclonal antibody and is currently approved for the treatment of severe rheumatoid arthritis, ankolysing sponglylitis and moderate to severe Crohn’s disease, among others.

The Reverse Signaling Apoptosis Bioassay is a critical method required by regulatory authorities for the licensing of Humira and Remicade. The bioassay copies an important TNF-Alpha biology component where membrane bound TNF-Alpha acts as a receptor and mediates a negative feedback system following binding by the TNF2 receptor. This leads to cytokine suppression and apoptosis induction in TNF-Alpha producing cells, resulting in the dampening of elevated immune response.

“Once bound to membrane TNF-Alpha, Humira is capable of eliciting this reverse signaling mechanism providing a mechanism of action distinct from the more commonly assessed neutralisation of TNF-Alpha-mediated responses and the recruitment of effector functions to mediate ADCC and CDC. The reverse signaling apoptosis assay should not be confused with the apoptosis neutralisation assay, which are tools to evaluate the different mechanisms of action of Humira,” explains BioOutsource.

The company announced that Dr. Galbraith will present a webinar (How Biological Characterisation is improving speed to market for BioSimilars) together with Business Review Webinars this month.

“The webinar will present how the biological characterization of BioSimilar Monoclonal Antibodies plays a critical role in the development pathway for Biosimilars. I am looking forward to presenting our extensive experience in this area and engaging with thought leaders in the industry in the Q&A section,” said Dr. Galbraith.

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