The majority of biopharmaceutical recalls are prompted by problems related to primary packaging according to data from the US Center for Biologics Evaluation and Research (CBER), with the presence of “visible particles” being among the most common.
It is widely acknowledged that these problems often relate to interactions between the drug and the vial or syringe in which they are packaged, but to date the specific mechanisms responsible for product degradation are poorly understood.
To improve this understanding Unilever Ventures-backed firm Arecor and the Centre for Process Innovation (CPI) have teamed up to examine the role formulations play in the stability of biologics.
Critical components
The research, which will be carried out at the CPIs laboratory in Wilton before transferring to the National Biologics Manufacturing Centre (NBMC) in 2015, will be an assess the role key components of drug packaging and delivery devices have on shelf life.
A CPI spokesman told BioPharma-Reporter.com that: “We believe the degradation of some biopharmaceutical products may be due to interactions with the rubber components of the devices and silicone oil used in prefilled syringes may also be causative.”
He added that: “The aim is to find formulations that can alleviate these effects” explaining that the idea will be to help biopharmaceutical firms decide formulation and container selection strategies which will counteract these effects.
This was echoed by Arecor spokesman Nick Darton who told us that: "I would add that the silicone oil can cause degradation of proteins as well as appearance of subvisible particles, however its use is necessary in glass prefilled syringes to act as a lubricant.
"We are studying a formulation approach to stabilise the biopharmaceuticals from the degradation process caused by the silicone oil as well as other components of the syringe. These other components include chemicals that leach out of the rubber stopper and metals found in the walls of glass syringes/vials left over from their manufacturing process."