Somerset, N.J. – December 15, 2016 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced 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.
“Catalent has significant experience partnering with companies for the successful development of antibodies for innovative applications,” commented Mike Riley, Vice President & General Manager of Catalent Biologics. “PATH is a leader in the field, working with partners to pioneer vaccine development approaches that could someday 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.
For more information on Catalent Biologics, visit www.catalentbiologics.com
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About GPEx ® technology
Catalent performs GPEx programs at its state-of-the-art commercial biomanufacturing facility in Madison, Wisconsin, which 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.
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 9,500 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com