laboratory informatics
development, Meek adds. ‘Companies have realised that if they are going to take advantage of all this data and use it as part of their QbD approach, then they need all that data centralised and collated into a single, holistic solution, and that provides opportunities to leverage multivariate data available for advanced analytics not just for a single product, but potentially for designing processes and predicting bottlenecks or manufacturing problems for similar products in development. Tis ability to transfer knowledge and make it relevant to multiple products is in part what’s driving paperless laboratory initiatives, and convergent informatics. R&D departments are talking to manufacturing departments because PAT data from process and manufacturing stages can also feasibly be used to inform compound selection and product development at an early stage.’
A single interface for integration Te application of QbD and PAT requires the application of flexible technologies that can capture real time data and present it, in combination with off-line analytical and process data from LIMS and automation
systems, to enable immediate decision making and changes in process parameters. Siemens’ SIPAT platform, for example, has been developed as a single interface to facilitate the implementation of PAT in a pharmaceutical manufacturing setting, Francois claims. ‘Te system can be integrated with, configure and control a range of analytical instrumentation, and collects, stores and reports all analytical data. SIPAT is also easily integrated with existing LIMS and automation systems to provide a single platform for accessing, combining, querying and analysing multivariate data in a range of formats, and making immediate changes to parameters to maintain optimum processing and manufacturing quality.’
Enabling efficient process design Te SIPAT model builder and report manager enable the user to search and request data including context and calibration data, so that all necessary information can be used in modelling soſtware packages. ‘With SIPAT you get all your relevant quality and process data presented in one single tool,’ Francois explains. ‘SIPAT can retrieve all the process, analytical and LIMS data from a single or
multiple time points, and feed that data into mathematical packages and soſtware, including Siemens’ own tools and third party platforms. It means that you can view your processes from a much wider perspective, and gain new insights into the impact of changing either individual parameters or multiple parameters. Te ability to use data from
WE MAY BE ON THE BRINK OF A NEW GENERATION OF TOOLS
multiple source layers, such as LIMS, PAT and automation, will ultimately enable the design of much more efficient processes and higher- quality products, which brings us right back to the underlying concept of QbD.’ Tis ability to manage, query, report and
manipulate multivariate data fits in with the ultimate goal of big data management and integration; effectively getting the maximum utility from data from disparate sources. We may be on the brink of a new generation of tools that enable the smarter utilisation of data from multiple layers that may otherwise remain as dead and unusable data. l
OpenACC 2.5
www.openacc.org
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