Arecor and the Center for Process Innovation (CPI) Biologics are working on a project to enhance the compatibility of biologics with their containers, and thereby, improve the stability and shelf-life of these medicines throughout transportation and storage.
The components of vials and syringe can adversely affect the stability of some biologics, causing degradation and making them unsuitable for administration. The collaboration between Arecor and CPI Biologics seeks to address this issue by determining the actual causative components and understanding the degradation mechanisms. The goal is to develop an efficient screening system that can detect compatibility issues during the development of novel biologics. The tool kit will enable the determination of formulation and container selection strategies that will counteract these effects and ensure the stability of biologics in both standard and state-of-the-art delivery devices.
The project starts with a proof-of-concept phase over a six-month period, and if successful, it could potentially transition into a development phase to establish standardized procedures and tools for the biopharmaceutical industry.
This is the first industry partnership that CPI Biologics has undertaken in association with its £38m National Biologics Manufacturing Center (NBMC) and will be performed at CPI’s Wilton laboratories and clean rooms in advance of the opening of the NBMC in 2015.