BioOutsource Ltd. has announced the launch of the flagship Reverse Signaling Apoptosis Bioassay, adding to the extensive range of characterization services offered by the company. The assay is a critical method, required by the regulators for licensure of Humira and Remicade BioSimilars.
The Reverse Signaling Apoptosis bioassay replicates a critical component of TNF-Alpha biology whereby membrane bound TNF-Alpha acts as a receptor, mediating a negative feedback system following binding by the TNF2 receptor.
This results in cytokine suppression and the induction of apoptosis in TNF-Alpha producing cells, thereby dampening the elevated immune response.
BioOutsource CSO, Dr Daniel Galbraith commented; “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 the full biological characterization of Humira and Remicade BioSimilars.”
In addition, BioOutsource also announced that Dr. Galbraith will shortly present a webinar on How Biological Characterization is improving speed to market for BioSimilars.
Dr. Galbraith commented “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”.
The webinar is being hosted in partnership with Business Review Webinars on 27th March 2014 at 3pm GMT.
BioOutsource has also announced that it will shortly be exhibiting at CHI’s Biotherapeutics Analytical Summit in Baltimore, USA on 24-28th March 2014, followed by Informa’s, BioProcessing International European Summit in Prague, Czech Republic on 2-3rd April 2014.