Manufacturing service will scale production of growth hormone developed using ‘ProFuse’ Technology
Keele and Sheffield, UK, 23 November 2015: Cobra Biologics (Cobra), international CDMO of biologics and pharmaceuticals, has been appointed by the University of Sheffield to provide a comprehensive manufacturing service for a potential growth hormone (GH) antagonist created using ProFuse™ Technology originally developed by the University of Sheffield. This work will allow Sheffield University to progress toxicology trials and prepare for Phase 1 clinical trials, with the help of the Medical Research Council (MRC): Developmental Pathway Funding Scheme (DPFS) provided by the UK Biomedical Catalyst.
ProFuse Technology is a novel fusion technology in which hormones are fused to the extracellular domain of their receptors. The resulting fusion protein has a longer circulation half-life than the native hormone as it is larger in size, and is able to compete with the natural hormone for receptor binding.
Cobra will be using its cell line development service, maxXpress, to produce the GH antagonist fusion protein. By disrupting GH binding and thus preventing the cellular changes normally initiated by the hormone, it is hoped that the protein will be successful in the treatment of patients suffering from Acromegaly, a condition of excessive body growth due to GH over-production. This condition results in increased morbidity and mortality.
Peter Coleman, CEO Cobra Biologics commented: “I am very pleased that The University of Sheffield has chosen Cobra to manufacture the ProFuse growth hormone antagonist. Cobra’s maxXpress service has proven very popular with customers. The service combines the UCOE technology and Cobra’s cell development team providing the optimum combination to take their protein forward to clinical trials”.
Professor Richard Ross, the University of Sheffield’s Principle Investigator on the DPFS grant said “This is a major step forward in our MRC funded programme to develop a new cost-effective treatment for patients with Acromegaly. We are delighted to work with Cobra who has the experience and technology to rapidly manufacture our ProFuse growth hormone antagonist for clinical trials.”
As part of the comprehensive service Cobra will be providing scale-up and non-GMP manufacture at 250L, formulation development and fill-finish.
The maxXpress service combines Cobra’s cell line development team with Ubiquitous Chromatin Opening Elements (UCOEs) technology to provide a rapid solution to producing monoclonal antibodies and recombinant proteins from CHO-S cells. UCOE containing vectors have been shown to markedly enhance the expression of a wide variety of intracellular, secreted and membrane-bound proteins. Inclusion of a UCOE (4-8 kb in size) in a eukaryotic expression vector permits efficient expression in the vast majority of stable clones, whereas with conventional vectors only a minor proportion of transfectants demonstrate high-level expression. There is therefore no need for amplification and expression has been demonstrated to be stable over 130 generations. The combination of UCOE and CHO-S allows the generation of high yields of recombinant proteins.
About the University of Sheffield (www.sheffield.ac.uk)
With almost 25,000 of the brightest students from around 120 countries, learning alongside over 1,200 of the best academics from across the globe, the University of Sheffield is one of the world’s leading universities.
A member of the UK’s prestigious Russell Group of leading research-led institutions, Sheffield offers world-class teaching and research excellence across a wide range of disciplines.
Unified by the power of discovery and understanding, staff and students at the university are committed to finding new ways to transform the world we live in.
In 2011 it was named University of the Year in the Times Higher Education Awards and in the last decade has won four Queen’s Anniversary Prizes in recognition of the outstanding contribution to the United Kingdom’s intellectual, economic, cultural and social life.
Sheffield has five Nobel Prize winners among former staff and students and its alumni go on to hold positions of great responsibility and influence all over the world, making significant contributions in their chosen fields.
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About the MRC
The Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-one MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. www.mrc.ac.uk
About Biomedical Catalyst
The Biomedical Catalyst (BMC) is a joint programme run by the Medical Research Council and Innovate UK providing responsive and effective support for the best translational life science opportunities arising in the UK. Grants are available to UK academics and small and medium enterprises (SMEs) seeking to move their research more quickly from discovery to commercialisation to deliver patient benefit. Any UK small or medium-sized business or academic institution undertaking research and development has been able to apply to the BMC on a rolling basis, with applications assessed by independent experts.
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