Somerset, NJ & Boston, MA, August 2, 2016 – Catalent Pharma Solutions, a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Zumutor Biologics Inc., a developer of biosimilars, novel biobetters and New Biological Entities, today announced a successful research study, combining Catalent’s proprietary GPEx® technology and Zumutor’s fucose knockout platform, to create new and more efficacious antibodies.
The GPEx technology platform creates stable, high-yielding mammalian cell lines for even the most difficult to express proteins. The advantages of applying GPEx technology span from early feasibility studies and clinical manufacturing, to commercial scale production.
Working in partnership, Catalent and Zumutor have created a fucose knockout GPEx cell line expressing high levels of an anti-HER2 antibody. The resulting modification completely removes fucose from the antibody, resulting in greatly enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) without impacting production levels. The study was conducted in Zumutor’s research and development facility in Asia.
Kavitha Iyer, Chief Operating Officer of Zumutor, commented, “Zumutor’s fucose knockout technology enables us to create new and more efficacious antibodies. The inherent stability of GPEx cell lines makes these modifications possible and allows GPEx cell lines to be modified quickly, to produce a more potent antibody. Our partners have the potential to leverage this improved technology in therapeutic antibody product development, and generate a new regime of drug products engineered toward patient benefits.”
“GPEx technology was designed to offer our partners advantages over conventional cell line engineering systems, including increased flexibility and higher, more stable yields,” added Mike Riley, Vice President & General Manager of Catalent Biologics. “The use of GPEx technology, in combination with Zumutor’s afucosylation platform, has shown exciting results, and has the potential to be applied to other antibodies that could benefit from ADCC enhancement as part of their development programs.”
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About GPEx® technology
Catalent’s proprietary GPEx® technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial scale production. To date, seven GPEx based antibody and protein products are approved and marketed and 34 therapeutic candidates are currently in the clinic across the world.Catalent performs GPEx programs at its state-of-the-art biomanufacturing facility in Madison, WI., which was completed in June 2013. Designed for flexible cGMP production from 10 L up to 1,000 L, and non-GMP production up to 250 L, the site features extensive single-use technologies and unidirectional flow to maximize efficiency and safety.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,700 people, including over 1,000 scientists, at 31 facilities across 5 continents, and in fiscal 2015 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
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Zumutor Biologics Inc is a pre-clinical stage biologics discovery and development company, headquartered in Woburn, MA with Research & Development facility in Bangalore, India. With combined team experience of over 100 years in global institutes and companies, Zumutor‘s holistic expertise encompasses state-of-the-art technologies and development models. At Zumutor, we combine two proprietary technology platforms to create new glyco-engineered monoclonal antibodies which identify unique target epitopes.Our goal is to develop new drugs with breakaway potential in Oncology and Autoimmune disorders. We are committed to creating portfolio value for partners, both regional and across the world with biotherapeutics that meet international quality standards. For more information, please visit www.zumutor.com