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.”
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