QC Lab of the Future
The QC Lab of the future team are working on sharing common approaches and best practices to enable digitalization of the QC lab to maximize efficiency within the laboratory.
Technology advancements are not well supported
Quality control (QC) labs in the biopharmaceutical industry have fallen behind the digital enablement of the manufacturing environment. Test execution is not automated, partly because a lot of lab equipment cannot yet be controlled digitally. Technicians use non-integrated systems, often with fixed user interfaces based on reports and documentation/paper rather than individualized personal user experiences; they are not guided or assisted by technology. Data is not captured automatically or consistently, and it is not exposed for external usage in a standard format, making it very difficult to use analytics to optimize outcomes. This situation can also lead to significant data integrity concerns with regulatory agencies.
Technology advancements for at-line and in-line testing are not well supported. The QC lab of the future program sets out a manifesto of what things need to be improved, over a realistic three-year timeframe.
- Getting everything ready for testing smoothly and efficiently
- Automated testing with data capture
- And managing that data
With about 50 topics, it is a big vision. Working in collaboration with lab equipment and software vendors on a shared vision for digital technology to form the basis of the QC lab of the future, our vision is that the lab of the future should leverage modern approaches and best practices to implement tools and technologies that maximize efficiency and performance of lab processes and operations.
Manifesto for improvement
Within that overall framework, the group has prioritized a set of topics to progress on collectively. Automation and data integration for lab equipment is the basis for many other capabilities. We’ve looked at different strategies for data aggregation and data integrity. There are many new opportunities (as well as challenges) with robots and cobots in the lab, and with augmented reality, virtual reality and speech interfaces leveraging AI technologies to assist users, create efficiencies, and increase ‘right first time’.
We are working to bring that manifesto to life in four ways:
Communicating it to the industry, a stake in the ground, a reference point.
Biomanufacturers are sharing their own strategies for their lab of the future, and working to align with each other and the manifesto – which makes them more credible, sustainable and thorough, and the alignment is needed if we are going to see industry-wide change.
Some key vendors to the lab are sharing their roadmaps and our question is “How are you going to take us towards this vision of the lab of the future”. It is a collaboration and we are starting to see change as they update and increase their digital enablement.
Finally, we are pushing forward some of the key topics, defining the design options, articulating benefits of change to all the stakeholders and looking at some of the new challenges – for example, next generation sequencing in the QC labs. Establishing common approaches is really important, particularly with the regulator. All of which help us progress with the QC lab of the future so that there is improved efficiency, performance and predictability, reducing the lead time on QC testing so we get closer to instant release. This could make a significant difference in the industry.
QC Lab of the Future deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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