91香蕉视频 & Minomic Collaborate To Bring New Prostate Cancer Treatment To Market
Somerset, N.J. 鈥 August 27, 2014 鈥 91香蕉视频, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today 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, 91香蕉视频 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 91香蕉视频鈥檚 proprietary GPEx庐 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 91香蕉视频鈥檚 state-of-the-art biomanufacturing facility in Madison, WI.
鈥淓arly signs in the study are extremely encouraging,鈥 commented Brad Walsh, CEO of Minomic. 鈥We are pleased to be working with 91香蕉视频 on this exciting project as 91香蕉视频鈥檚 flexibility on smaller cGMP batch production allows material supply quickly and efficiently.鈥濃淲e 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 91香蕉视频 is our ultimate aim.鈥
鈥GPEx technology offers many advantages compared to conventional cell line engineering systems, including increased flexibility and higher, more stable yields,鈥 commented Barry Littlejohns, President of Advanced Delivery Technologies for 91香蕉视频. 鈥We hope that this therapeutic collaboration, combined with Minomic鈥檚 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.鈥
Developed in response to customer demand, 91香蕉视频鈥檚 Madison biomanufacturing facility, constructed through an investment of approximately $20m and completed in June 2013, quadrupled the company鈥檚 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.
About Minomic
Minomic International Ltd is an Australian privately owned biomarker discovery company specialising in in-vitro-diagnostics (IVD), diagnostic imaging and therapeutics for prostate cancer. Minomic has developed the in vitro diagnostic test called MiStat鈩 for the early detection of prostate cancer. The key reagents, including the MIL-38 antibody and antigen and related applications are protected by international patents.
Following 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-center clinical validation in mid-2014.
Minomic is interested in partnerships or collaborations with a larger pharmaceutical/diagnostic global partner able to produce, register and distribute the MiStat鈩 ELISA test and collaborate through clinical validation, registration and commercialization of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate cancer.
About 91香蕉视频
91香蕉视频 is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 90 years serving the industry, 91香蕉视频 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. 91香蕉视频 employs approximately 8,000 people, including over 1,000 scientists, at 27 facilities across 5 continents. 91香蕉视频 is headquartered in Somerset, N.J. For more information, visit www.catalent.com.