Biosimilar cell lines available from AscentGene
Because patents for many of biological drugs worldwide have been or will soon be expired, the billion-dollar biosimilar market promises exciting opportunities but also lies in many challenges. As the FDA finally came up with a draft of guidance on biosimilars in May, 2014 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf) development of highly stable, regulatory-acceptable and highly productive cell lines is probably the most critical challenge in the path of biosimilar development.
AsscentGene has been specialized in developing stable cell lines and early stage of drug development for therapeutic biologics including recombinant proteins, monoclonal antibodies and vaccines. Our clients include National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Development (NICHD), Food and Drug Administration (FDA) and pharmaceutical/biotechnology companies worldwide.
Currently, AscentGene offers license opportunities for fully validated and characterized stable cell lines of following biosimilars:
CHO cell line for production of Humira, a fully human monoclonal antibody against TNFa for the treatment of rheumatoid arthritis (DrugBank: DB00051). Because of additional indications for ailments of plaque psoriasis, Crohn’s diseases and ulcerative colitis, Humira has become the number one selling drug worldwide for $11 billion in 2013. AscentGene’s stable cell line was developed based on the clone D2E7 and secreted D2E7 monoclonal antibody can be isolated from the supernatant.
CHO cell line for production of Rituxan (Rituximab), a monoclonal antibody against human CD20. This blockbuster anti-cancer and rheumatoid arthritis drug ranks top 6 in 2013 and is all over biosimilar developers’ radar. However, many biosimilar developers including Celltrion, Teva and others stopped their late stage of clinical trials because of difficulties for creating a biosimilar copy of Rituxan. AscentGene assures its Rituxan cell line producing Rituxan biosimilar with similar structure, activity, efficacy and high yield.
CHO cell line for production of Herceptin, a chimeric monoclonal antibody against human her2 oncogene. Herceptin was the pioneer in HER2-positive breast cancer franchise, which led increase in international sales of 11% and ranked top 8 best selling drug in 2013.
Services for developing other biosimilar stable cell lines are available upon request.
For additional information or to request a project proposal, please contact us at 1-301-476-0885 or <firstname.lastname@example.org>. We will be happy to assist you.