Catalent Joins Global Initiative to Develop Malaria Vaccine

Catalent Biologics collaborates with PATH Malaria Vaccine Initiative to create antibodies for malaria vaccine research and development.

Catalent Pharma Solutions, 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 Madison, WI facility, for further investigation by MVI and its partners.

“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 partnerships, PATH helps drive the development of better malaria vaccines. 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.

Catalent’s commercial biomanufacturing facility in Wisconsin was completed in June 2013. Designed for flexible cGMP production from 10 L up to 1,000 liters, and non-GMP production up to 250 liters, the site features extensive single-use technologies and unidirectional flow to maximize efficiency and safety. Catalent recently announced the commencement of work to extend its Madison facility and add 22,000 square feet of space accommodating two 2,000 liter bioreactors that will allow the company to support late-phase clinical, and commercial production of up to 4,000 liter batches. www.catalentbiologics.com.

(Source: Catalent Pharma Solutions)