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.