Change notification for single-use systems
Change notification is an important aspect of biopharmaceutical manufacture. Through the licensing process drug manufacturers have a legal responsibility to maintain control of their processes, to deliver consistent products and outcomes. This includes being aware of, being able to assess and responding to changes that may impact their product so as not to adversely effect product quality or supply. At the same time supply partners (throughout the value chain) need to be aware of the impact necessary changes may bring, how they can support end users and manage necessary changes smoothly.
Single-use systems (SUS) are an increasingly strategic tool within the biopharmaceutical industry allowing rapid scale up or scale out in response to market demand and/or clinical trial results. They provide a mechanism by which capacity can be increased with low capital cost and support reductions in overheads through enabling faster changeovers and use of facilities for multiple products and are likely to play a huge role in making personalized medicines such as cell and gene therapies accessible.
This flexibility is not without challenges that need to be managed
- Firstly, the ability to rapidly increase or decrease capacity implies that there is a high turnover of single-use systems, with any individual system being used for a short period of time (typically one manufacturing process). This means that new systems are constantly being manufactured to replace those that have been used.
- Secondly, single-use systems consist of numerous plastic components derived from different suppliers.
As such, they are prone to changes, including alterations in construction materials or modifications in manufacturing processes. Such changes may originate at the immediate supplier or farther back in the supply chain as a result of product improvements, process improvements, part discontinuation, or even business decisions such as manufacturing site relocation.
This combination of the high strategic value of single use systems, their susceptibility to change and the criticality of good change management to biomanufacturers made change notification for single use systems an attractive area of focus for biomanufacturers and supply partners.
The complexity of the issue, arising through the nature of the supply chain for these systems and the failure of previous efforts at a company to company level necessitated a collaborative whole industry approach that BioPhorum is uniquely placed to deliver. Working with our partners on this project at the BioProcess Systems Alliance (BPSA) provided extended reach into the supply chain.
The timeline below shows the journey the team has taken in developing these practices