Leveraging our existing technology to develop a therapeutic antibody in conjunction with Catalent is our ultimate aim.” We are already close to bringing a new, non-invasive testing kit for prostate cancer to market using the same antibody target. “Catalent’s flexibility on smaller cGMP batch production allows for material supply to be quickly and efficient. “Early signs in the study are extremely encouraging,” commented Brad Walsh, CEO of Minomic. If the initial clinical study proves successful, the antibody will be produced at Catalent’s state-of-the-art biomanufacturing facility in Madison, WI. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production. 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 companies agreed that Catalent will initially produce the antibody for a clinical study with a view to larger scale production subject to a successful outcome. Minomic has developed an in vitro diagnostic test called MiStat™ for the early detection of prostate cancer.įollowing a successful proof-of-concept clinical study on 125 Australian patients demonstrating good sensitivity and specificity for discriminating prostate cancer patients from those with benign prostatic hyperplasia or no disease, the test is about to enter a multi-centre clinical validation in late-2014. Catalent, a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Australian biomarker research company, Minomic International Limited, agreed to collaborate in developing MIL-38, an antibody drug conjugate (ADC) for prostate cancer therapy.