Somerset/New Delhi: Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it has signed an agreement with PATH, an international nonprofit organization and a leader in global health innovation, to advance a project funded by its Malaria Vaccine Initiative (MVI).
Under the agreement, Catalent Biologics will employ its proprietary GPEx® cell line technology, coupled with a state-of-the-art ambr® workstation, which mimics the characteristics of classical bioreactors at micro scale, to develop, optimize the process for expression, and manufacture antibodies under cGMP conditions at its state-of-the-art Madison, Wisconsin facility, for further investigation by MVI and its partners.
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 Biologics Inc is a pre-clinical stage biologics discovery and development company, headquartered in Woburn, MA with Research & Development facility in Bangalore, India.
“Catalent has significant experience partnering with companies for the successful development of antibodies for innovative applications,” commented Mike Riley, Vice President and General Manager of Catalent Biologics. “PATH is a leader in the field, working with partners to pioneer vaccine development approaches that could ultimately contribute to malaria elimination efforts. We are excited to be able to apply our technology and expertise to advance this important program.”
PATH’s MVI is working to accelerate the development of malaria vaccines and to ensure access where they are needed most across the globe. Through innovative partnerships such as this, PATH helps drive the development of better malaria vaccines. Through these strategic partnerships, MVI maintains a portfolio of candidates, both preclinical and early clinical, and at least one advanced clinical project.
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.