Catalent has announced that it is collaborating with privately held Australian biomarker research company, Minomic International Limited, to develop MIL-38, an antibody drug conjugate (ADC) for prostate cancer therapy. Under the agreement, Catalent will initially produce the antibody for a clinical study with a view to larger scale production subject to a successful outcome.
The antibody production project incorporates Catalent’s proprietary GPEx® technology, which creates stable, high-yielding mammalian cell lines with high speed and efficiency, typically getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.
Should the initial clinical study prove successful, the antibody will be produced at Catalent’s state-of-the-art biomanufacturing facility in Madison, WI.
“Early signs in the study are extremely encouraging,” commented Brad Walsh, CEO of Minomic. “We are pleased to be working with Catalent on this exciting project as Catalent’s flexibility on smaller cGMP batch production allows material supply quickly and efficiently.”“We are already close to bringing a new, non-invasive testing kit for prostate cancer to market using the same antibody target. Leveraging our existing technology to develop a therapeutic antibody in conjunction with Catalent is our ultimate aim.”
“GPEx technology offers many advantages compared to conventional cell line engineering systems, including increased flexibility and higher, more stable yields,” commented Barry Littlejohns, President of Advanced Delivery Technologies for Catalent. “We hope that this therapeutic collaboration, combined with Minomic’s pioneering work in non-invasive test kits for early detection of prostate cancer, will enable Minomic to help bring a potentially life-saving treatment to market as quickly as possible.”
Developed in response to customer demand, Catalent’s Madison biomanufacturing facility, constructed through an investment of approximately $20m and completed in June 2013, quadrupled the company’s biologics manufacturing capacity. Designed for flexible cGMP production from 10L up to 1000L, and non-GMP production up to 250L, the site features single-use technologies and unidirectional flow to maximize efficiency and safety.