Ondek® has partnered with professional organisations that provide expertise in intellectual property portfolio development, model systems for non-clinical studies, quality manufacture and production, and immunology and allergy. As part of its outsourcing strategy to access specialist skills and experience, Ondek® contracts and collaborates with qualified consultants in areas such as quality management systems for product development, clinical trial design and regulatory approval pathways.
University of Western Australia
Ondek® has contracted with the University of Western Australia (“UWA”) to use laboratory and office space for the project. This specifically includes access to appropriate facilities and PC2 licensing in order to carry out production of GMO organisms. The arrangement with UWA ensures that Ondek® has access to all of the facilities and most of the equipment required to successfully complete the project. The facilities include laboratory space and key equipment in the newly established Marshall Centre for Infectious Diseases Research which opened in 2008.
Ondek® is working with Exto Partners, a leading Australian venture capital and private equity investor. Exto Partners assist leading Australian companies to transform their R&D projects into viable commercial ventures. Exto Partners also invests the capital and the skills required to achieve success in the domestic and international marketplace. However, unlike other venture advisors, we partner with the founder team to form the nucleus of the management team and share responsibility for success of the project.
Established in 1949, FB Rice has grown to be one of the Australia’s leading patent and trademark firms. Our biotechnology team is widely respected for the results they achieve in a field that is both highly technical and fast-evolving. We work closely with a broad range of local and overseas biotech companies, including small to medium entities, big pharma and generics companies as well as academic and research institutions to protect their intellectual property and help them avoid infringing competitor’s intellectual property rights.
Our biotechnology team strives to treat our client’s intellectual property not in isolation but as part of their overall business strategy. Our team members are both highly legally and technically qualified but importantly, also understand business and can therefore help you navigate the IP landscape to find practical, workable solutions.
Ondek® require a scalable manufacturing process for production of Helicobacter pylori cells which will be used as therapeutic product that plays a role in immunomodulation. The scalable process needs to be compatible with GMP to enable production of a therapeutic agent suitable for testing and use in human clinical trials.
Ondek® and CSIRO are working together to develop new methods for the cultivation of H. pylori that will ultimately enable production of the hundreds of litres of bacterial cells needed for clinical trials. The project will draw on skills from CSIRO’s Microbial Fermentation Team which is led by Dr Geoff Dumsday especially expertise in scale-up of microbial processes and in particular is targeting the development of methods for growth of H. pylori in stirred-tank bioreactors. The research will be carried out at CSIRO’s Future Manufacturing Flagship state-of-the-art pilot-scale Fermentation Facility located in Clayton. The CSIRO facility is equipped with a range of computer controlled fermenters as well as appropriate processing equipment such as centrifuges and tangential flow filtration systems.
3P Biopharmaceuticals is a leading European CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products. 3P offers its customers solutions at all stages of bio drug development: from initial research, preclinical and clinical phases to commercial phases. Its extensive experience in projects covering all stages of the process development and manufacturing in three different expression systems (mammalian, bacterial and yeasts), its flexibility and adaptation with its innovative technology and its vast human capital have made it a reference for the European market.
Its notable technical successes have led it to manufacture over 50 molecules for over 30 customers from countries such as Norway, France, United Kingdom, Germany, Switzerland, Belgium, The Netherlands, Australia and the United States. In 2017, 3P Biopharmaceuticals is celebrating its 10th Anniversary in a context of international success. In just 10 years, it has managed to build a first-tier facility with a quality system in line with European and US regulations. 3P has a highly qualified staff – 57% of its more than 150 employees hold doctorate and/or master’s degree in areas such as chemical sciences, pharmacy or engineering.
LEUKOCARE closely collaborates with Ondek in the course of developing a best-in-class formulation for Ondek’s ImmBALANCE® product candidate based on LEUKOCARE’s proprietary Stabilizing and Protecting Solutions (SPS®) formulation technologies. SPS® provide superior protection and stability of proteins like biopharmaceuticals during processing and storage. They allow the development of pharmaceutical formulations in a shorter period of time, thus resulting in reduced costs, shorter time to market and a much higher probability of success. LEUKOCARE is a privately owned biotechnology company headquartered in Munich, Germany.
Telethon Kids Institute
The Telethon Kids Institute is a leader in child health research. Our goal is to make a real difference to the lives of children and their families at home in Australia and across the globe. We’re a new kind of research institute, one with a bold blueprint to bring together community, researchers, clinicians, policy makers and funders to do the best research using the brightest minds to find the right outcomes for kids and young people everywhere.
We believe that every child deserves the best start in life and that’s why kids are at the heart of everything we do. With over 500 staff and more than 200 research projects currently underway, we’re working hard across four key research focus areas – the Early Environment, Brain and Behaviour, Chronic Diseases and Aboriginal Health. Our aim is clear – to discover the causes of childhood illness and disease, to come up with ways to prevent them and to find the best ways to treat them so the work we do can have real impact. Telethon Kids Institute is proud to be working with Ondek® in the field of allergy research.
Murdoch Childrens Research Institute
Murdoch Childrens Research Institute (MCRI) is the largest child health research institute in Australia, and one of the top 5 globally. More than 1500 staff are working across a broad portfolio spanning population/public health and laboratory sciences. MCRI has a highly translational focus with over half of the 70 research group leaders being clinically trained resulting in more than 713 peer reviewed publications in 2013, a third of which are in the world’s top journals, and a rich pipeline of new products and technologies, 9 of which have been brought to market.
The institute, together with its campus partners the Royal Children’s Hospital and the University of Melbourne has established a specialist paediatric clinical trials centre leveraging its strengths in trials governance, ethics, statistics, trial design and conduct, and will work closely with Ondek® in clinical evaluation of Ondek’s new products.