The Centre for Process Innovation (CPI) is working with Arecor to enhance the compatibility of biologic medicines with containers, and thereby improve stability and shelf life throughout transportation and storage. This is the first industry partnership that CPI Biologics has undertaken in association with its £38m National Biologics Manufacturing Centre (NBMC) and will be performed at CPI’s Wilton laboratories and clean rooms in advance of the opening of the NBMC in 2015.
The components of vials and syringes have been found to impact adversely on the stability of some biologics, causing degradation which can render the medicine unsuitable for administration and in some cases require product recalls. Although this issue is widely recognised in the biopharmaceutical industry, the actual causative components and the degradation mechanisms have not been fully elucidated. This collaboration between Arecor and CPI Biologics will aim to address this issue by determining the root causes of degradation pathways and designing an efficient screening system to allow early detection of compatibility issues during the development of novel biologics. Arecor’s and CPI’s expertise in formulation and biopharmaceutical characterisation, respectively, will be deployed to develop a tool kit. This will enable the determination of formulation and container selection strategies which will counteract these effects, and ensure the stability of biologics in both standard and state-of-the-art delivery devices.
The output of this project could be of great benefit for derisking the global biologics discovery and manufacturing supply chain, in addition to aiding healthcare providers by cutting costs, reducing waste and enabling wider patient access to these beneficial therapies.
The project will begin with a proof-of-concept phase over a 6 month period, with potential to transition into a development phase aimed at establishing standardised procedures and tools that can be made available across the industry.
Dr Chris Dowle, Director of Biologics at CPI said “We are delighted to have formed this partnership with Arecor and hope this will be the first of many such projects.”
Tom Saylor, CEO of Arecor said “the issues related to incompatibility with containers is of increasing importance and we are confident that our technology can be adapted to address these problems. Our partnership with CPI under the NBMC collaboration framework represents a tremendous opportunity to accelerate the development of Arecor’s capability in this area.”
Notes to the Editor
The Centre for Process Innovation is a UK-based technology innovation centre and part of the High Value Manufacturing Catapult. We use applied knowledge in science and engineering combined with state of the art development facilities to enable our clients to develop, prove, prototype and scale up the next generation of products and processes.
Our open innovation model enables clients to develop products and prove processes with minimal risk. We provide assets and expertise so our customers can demonstrate the process before investing substantial amounts of money in capital equipment and training. New products and processes can be shown to be feasible; on paper, in the lab and in the plant before being manufactured at an industrial scale.
By utilising our proven assets and expertise companies can take their products and processes to market faster. There is no down time in production as all of the process development is completed offsite and our technology transfer and engineering teams can help companies to transfer the product or process into full scale production at speed.
Arecor is a pioneer in the stabilisation of biologic molecules, a key challenge in the development of many therapeutic proteins, vaccines and diagnostics. Many proteins, peptides or vaccines are too unstable in liquid form to develop ready-to-use drugs, or are unstable at high concentrations. Arecor has developed a set of unique technologies to address these problems with the potential to revolutionise the self-administration of therapeutic medicines which can be used by patients. It has partnered with the world’s leading pharmaceutical and biotech companies to enhance the commercial value and practical utility of many different types of therapeutic proteins, peptides and vaccines.