Many will recognize that the biopharmaceutical quality control (QC) laboratories need much more digital enablement to align with the rest of the manufacturing environment.
Issues range from a lack of automation and data not being captured automatically or consistently for advanced analytics.
Change and industry collaboration is clearly needed – and a vision of the future has been delivered by BioPhorum through a new paper, Manifesto: Digital technology-based capabilities for the QC lab of the future.
The manifesto is a shared vision for digital technology that will help organizations maximize the efficiency and performance of their laboratory processes and operations. It is also an essential piece of the puzzle for adopting in-line monitoring and real-time release.
These improvements are crucial because, without change, organizations will see higher lead times for testing, greater batch variability and increased costs of testing. They will also find lower product yields and less predictable time and quality.
According to Jesse Cerutti, Solution Engineer, and John Kelleher, Senior Director of Digital Quality Solutions, both from Pfizer, the current state of QC laboratories is affected by a “general lack of innovation from the large technology vendors. Because of this, we find ourselves in a place where the laboratory applications we rely on often require that we use old technology and infrastructure components. Therefore, instead of being able to leverage laboratory platforms to improve processes, we are stuck in a pattern where these applications are increasing our technical debt with every passing day.”
Written by BioPhorum’s Lab of the Future Workstream, the manifesto was produced by a collaboration between 18 leading biopharmaceutical manufacturers. It expresses the user community’s view of what needs to be enabled by people, process and technology between now and 2024. It also gives a framework to help biomanufacturers, and the vendors of laboratory equipment and software, construct coordinated roadmaps for the future.
Within the manifesto framework, the team has a prioritized list of topics to progress during 2020–21. It plans to look at automation and data integration, the different strategies for data aggregation and data integrity, and the associated architectural partitioning and reference data foundations. The workstream will engage with laboratory equipment and software vendors to explain the manifesto and how to contribute to accelerate change and innovation in QC labs
The team will also consider opportunities and challenges with robots and cobots (collaborative robots, which work alongside humans) in the laboratory. And it will look at augmented reality, virtual reality and speech interfaces using AI technologies to help users create efficiencies and increase ‘right first time’ – all equipping the smart scientists to be effective in the lab of the future.
This BioPhorum manifesto and collaboration will act as a fundamental enabler to ensure that all parties, especially the vendors of laboratory equipment and software, can work together to create the laboratory of the future. Our strength in numbers will be crucial to creating a consistent industry voice and making this a success.