UK’s Center for Process Innovation and Arecor Initiate Biologics Supply Chain ProjectBy
The Center for Process Innovation (CPI), an UK-based technology innovation center and part of the High Value Manufacturing Catapult, a strategic initiative by the UK government to revitalize manufacturing, is working with the Arecor, a UK-based company backed by Unilever Ventures and specializing in the stabilization of biologics, to enhance the compatibility of biologic medicines with containers for improving stability and shelf life throughout transportation and storage. This is the first industry partnership that CPI Biologics has undertaken in association with its Â£38-million ($65 million) National Biologics Manufacturing Center (NBMC) and will be performed at CPI's Wilton laboratories and cleanrooms in advance of the opening of the NBMC in 2015. CPI is the process industry element of the UK government's national manufacturing strategy dubbed the High Value Manufacturing Catapult. NBMC is one of seven technology and innovation centers tasked with stimulating growth within manufacturing sectors throughout the UK.
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 recognized 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 and CPI will work to develop a toolkit to enable the determination of formulation and container- selection strategies, which will counteract these effects and ensure the stability of biologics in both standard and novel delivery devices. The project will begin with a proof-of-concept phase over a six-month period, with potential to transition into a development phase aimed at establishing standardized procedures and tools that can be made available across the industry.