Numera and Lucullus:

A viable PAT solution for modern bioprocessing

With the industry trending towards continuous bioprocessing, PAT solutions are essential tools in reaching the bioprocess 4.0 vision however, until now adoption has been slow. This has been attributed to a variety of reasons that mostly focus on perceptions of regulatory challenges as well as a general reluctance to adopt some of the game-changing technologies such as cloud computing and wireless communication required by many PAT components. It seems that for the moment at least, the industry as a whole has an “If it ain’t broke don’t fix it” mentality. However, in the advent of the COVID-19 pandemic, as well as an increasing demand to bring medicines to market faster; how long can the biotech industry continue to hold out?


Together, Lucullus and Numera form the realisation of a viable fully defined PAT solution. Both a powerful software solution that enables contemporaneous monitoring, control, data management, and a kindred piece of hardware that automates sampling and analysis while feeding back the resulting data for evaluation.

PAT solutions or Process Analytical Technologies, are defined as mechanisms to facilitate the design, analysis, and control of pharmaceutical development and manufacturing processes. This is achieved by measuring critical process parameters (CPPs) which ultimately affect a processes’ critical quality attributes (CQA). In the biopharmaceutical industry, this would apply to analysis of raw materials, real-time in-process monitoring and control, as well as intermediate and final product analysis. A fully implemented PAT solution would facilitate higher product quality while reducing the process development costs and time. For example, variations within CPPs would be reduced as well as the chances of human errors and introduction of contaminations. At the same time, automation would allow for an accelerated throughput as well as simplifying the operation of up or downscaling any given process.

In my previous article, I wrote about the revolutionary process information and management software by Securecell called Lucullus. In summary, the Lucullus software facilitates monitoring and control in-real time of processes across the manufacturing stream, with disparate data sources integrated and their outputs aligned into a single user interface. By itself, Lucullus is a compelling tool that can be implemented to any extent demanded by its intended application, up to the point of enabling a fully digitised and even continuous process. However, when paired with Securecell’s world leading autosampler/analyser Numera, a fully realised and viable PAT solution emerges.

Numera simplifies and automates process analytics across up and downstream manufacturing. Automated high-frequency sampling of small volumes (2-4 ml) of process intermediates can be taken at any point during manufacturing while maintaining sterility between samples. Using its native Lucullus software, Numera can provide reliable and precise results around the clock. The hardware itself comprises a system of self-cleaning modules that are able to sample and analyse up to 16 bioreactors or other process equipment. Samples are automatically taken, prepared, stored and/or analysed using HPLC or up to 4 3rd-party analysers with data fed back seamlessly into Lucullus for immediate or later evaluation.

With a combination of CFR21 Part 11 compliant software and hardware, the total PAT solution by Securecell passes regulatory compliance for cGMP and smaller laboratory scale applications. For more information on Lucullus and Numera by Securecell, please contact Sean Doran at BPES.

Article by:
Sean Doran
Technical Sales Specialist


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