By designing an efficient screening system to allow early detection of compatibility issues
The UK\'s Centre for Process Innovation (CPI) is working with Arecor, a pioneer in the stabilisation of biologic molecules based at Cambridge Science Park, to enhance the compatibility of biologic medicines with containers, and thereby enhance 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 take place at CPI’s Wilton laboratories and cleanrooms in advance of the opening of the NBMC next year.
The components of vials and syringes can have an adverse impact 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 is issue is widely recognised in the biopharmaceutical industry, the actual components causing the problem and the degradation mechanisms have not been fully established.
The partners 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 new biologics. Arecor’s and CPI’s expertise in formulation and biopharmaceutical characterisation, respectively, will be deployed to develop a tool kit. This will enable formulation and container selection strategies to be determined that will counteract these effects, and ensure the stability of biologics in both standard and state-of-the-art delivery devices.
The project will begin with a proof-of-concept phase over a six-month period, with potential to move 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, added: \'The issues related to incompatibility with containers are 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.\'