Catalent Biologics & Zumutor Collaborate to Develop Antibodies With Enhanced ADCC Activity

Catalent Pharma Solutions and Zumutor Biologics Inc. recently 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.

“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,” said Kavitha Iyer, Chief Operating Officer of Zumutor.

“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.”

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. For more information, visit www.catalent.com.

Zumutor Biologics Inc is a preclinical-stage biologics discovery and development company, headquartered in Woburn, MA, with a 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. For more information, visit www.zumutor.com.