The Qualification of Small-Scale Models Workstream addresses the gap in industry alignment and regulatory guidance
Small-scale models and their qualification are important steps of biopharmaceutical process development, characterization, and validation. Despite being required by regulatory bodies, there is no guidance on current best practices and companies use many different qualification approaches throughout the industry.
Building on existing practices across the industry
To overcome these hurdles and provide guidance on how to implement and qualify small-scale models, the Qualification of Small-Scale Models Workstream has produced an extensive paper called Justification of small-scale models: an industry perspective (to be published in April). Robert Luo, Scientific Director in Downstream Processing Development at GlaxoSmithKline, explained the process of writing the paper and how it took perspectives and practices from all member companies. “Before we wrote the paper, we shared our own practices. Then we did survey work while the paper was being written, which was then organized and clarified.” With varied approaches among different companies, achieving a cohesive paper was quite challenging.
Despite the varied approaches, the team collaborated to produce an extensive paper that will provide alignment across the industry, including regulatory authorities. To raise awareness of the paper and its value, the workstream will produce a series of webinars and present their findings at conferences.
“Our group has 28 companies, and we are growing at every meeting. We have a global range now, all from different continents – the US, Europe, and Asia. This is really beneficial to the entire industry.” – Robert Luo
Improving knowledge and driving alignment while maintaining flexibility
The paper will benefit the entire industry by increasing its overall knowledge and subsequently improving the use of resources and providing a faster implementation of technologies. However, it allows for flexibility as well, as companies can use what they learn as a guide to develop their own processes.“This paper is much more of a tangible tool that will give companies a real starting point of where to go. They will need to do their own research and develop details, but people won’t have to start in the woods anymore. They now have a sense of what has been done and what has been accepted in development activities,” said Pferdeort.
“When participating companies were surveyed to establish a common standpoint on how to do small-scale model qualification, we ultimately came up with a best practice in the field. This is one of the greatest benefits that this paper has.” – Kiran Andra