CPI has collaborated with Arecor to investigate ways to enhance the compatibility of biologic medicines with drug product containers and thereby potentially improve stability and shelf life throughout transportation and storage.
This project was the first industry partnership undertaken by CPI in association with its £38m National Biologics Manufacturing Centre which is due to open in September. The project, which commenced in 2014, was performed in CPI’s laboratories at Wilton, Redcar in advance of the opening of the new facility.
The components of drug product vials and syringes have been found to have an adverse impact on the stability of some biologics, causing degradation which can render the medicine unsuitable for administration, in some cases resulting in product recalls. Although this issue is widely recognised in the biopharmaceutical industry, the actual causative components and degradation mechanisms have not been fully elucidated. This collaboration has investigated the effects of selected silicone oils and other primary packaging materials on the stability of proteins to enhance our understanding of container related causes of degradation and the use of novel formulations to mitigate these effects.
The ability to stabilise therapeutic proteins using formulation as has been demonstrated during this project can provide great benefit for the global biologics manufacturing supply chain by cutting costs and reducing waste through increased shelf life and reduced product specification failures.
We are delighted to have formed this partnership with Arecor and hope this will be the first of many such projects to continue to improve the formulation of therapeutic proteins.Dr Chris Dowle
Director of Future Business, Healthcare - Centre for Process Innovation
Rapid development in pre-filled syringes for biologics in the last decade has led to increasing occurrence of stability issues due to interactions with primary packaging materials. The collaboration with CPI allowed us to gain crucial insights into the nature of these undesirable effects and make an important step toward effective formulation strategies to mitigate them.Dr Jan Jezek
Chief Scientific Officer, Arecor