Lab of the future
Overview
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 3 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.
This vision is explained in the Manifesto: digital technology-based capabilities for the quality control lab of the future which is intended to inform, educate and be the basis for collaboration between biomanufacturers and vendors of lab instruments and IT/OT solutions to make the vision possible. It expresses what the user community believes needs to be enabled by technology in the near future. It is a framework to enable both industrial laboratories and vendors of lab equipment and software construct their roadmaps.
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, 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.
Abstract
Data integrity is fundamental to comply with current good manufacturing practices (CGMP) and ensure patient safety. Unsurprisingly, quality control (QC) lab data are heavily scrutinized during audits as they directly support the quality, safety and efficacy of the product, and indicate the state of control of a facility. Most QC labs have worked hard to establish the fundamentals of data integrity. Many have digitized to eliminate paper, some systems have compliance features built in, and a series of mitigations and workarounds cover the rest, albeit with some inefficiencies and limitations. There have also been significant evolution of systems and business practices, rising expectations for efficient and thorough investigation capability, and the desire to go beyond compliance and get knowledge and insights through better access to data. Next steps in data integrity are key to the QC lab of the future and the digital maturity of the manufacturing capability as a whole.
Abstract
Most quality control labs in biomanufacturing have not yet achieved digital transformation. Lab processes are often manual which is slow and leads to errors and variability as well as long lead times. Now those traditional ways of working are further challenged by the drive towards inline monitoring and real time release testing, and by new cell and gene therapies with tiny batch sizes and short shelf-lives. The lab of the future is digital and requires much stronger IT for demand management and process automation, increasingly informed by data analytics and connected to manufacturing operations. This will be enabled by stronger IT security and operations, systems interoperability and governance, and data aggregation using common models, analytics and visualization. Huge changes in lab personnel skills and culture are needed to work with the systems and the data in these new ways.
