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In the beginning were bioprocess data

At the Securecell founders’ labs, the evolution of the Lucullus® Process Information Management System (PIMS) for data integration took place long before the term “Biopharma 4.0” was coined. Lucullus® digitalizes and integrates disconnected processes and ensures full data integrity in bioprocessing. Lucullus® is a true PIMS. It has been evolving over more than 25 years, and it is continuously being improved, offering new functionalities and features on a regular basis.

At its core, Lucullus® allows real-time data capturing and process control interaction with various devices. In addition to the standard unit operations, peripheral devices like sensors can be flexibly added on the software level.

Another crucial aspect for integration is the timely access and workflow optimization around sample-based analytics. Lucullus® offers sample management, nicely integrated into the process monitoring and control interface, supported by label printing and barcode scanning. Lucullus® gives the user a great tool to oversee and use all measurement data within a central interface optimized for the execution of parallel experiments.

Besides remembering material inputs to generate complete data sets and support traceability, Lucullus® offers tools to link processes with each other. It captures the seed train and provides a media management tool. The media management tool allows the digitalization of media kitchen operations with electronic recipes for lot creation, while at the same time ensuring full traceability from the raw material to the final process outcome by linking the media, feeds, and buffers to the respective processes.

All the information flows into a central, secure database that can span several labs or even sites.

The information is remotely accessible to analyze data, create predefined reports, or extract complete bioprocess data sets. Of course, Lucullus® also provides interfaces to integrate with other specialized tools.

As Lucullus® is vendor-agnostic and a generic SCADA package, it supports workflows across unit operations, i.e., connecting USP and DSP to implement continuous manufacturing, which is becoming increasingly important in PD labs (E2E, Real Time Release).

Lucullus® has been co-developed with major pharma and is used by hundreds of customers worldwide, the biggest ones integrating several sites and counting more than 250 reactors/process units with a scale from 15 ml (screening) to several cubic liter production vessels.

One of the major benefits of Lucullus® is the alignment of on-line signals and at-line sample-based signals in a timely manner, giving users a central monitoring and control interface for all crucial process parameters.

Securecell’s innovation has not been restricted to the development of integrative software, but also has been expanded by the development of a powerful PAT tool.

Integration & Centralized Data Managment
All bioprocess relevant data aligned, integrated, and centralized. A tremendously positive disruption and constructive reorganization of how bioprocess development in being done.

Numera® PAT—Low-volume, high-frequency automated sampling and sample processing

Numera®, Lucullus®’ analytic hardware companion, is a state-of-the-art automated sampling system.

It automates sample flow from vessel to analyzer and harbors modules for sample dilution and filtration. Samples are stored on a refrigerated sample collector or directly transferred to analytical systems such as HPLC instruments, metabolic analyzers, or cell counters.

Numera® frees the operators of the burden of daily sampling and sample processing (liquid handling) of up to 16 sampling lines (bioreactors) per system. While other sampling technologies lack proper integration with the surrounding environment in terms of data management, Numera® fully relies on the Lucullus® interface and its integration capabilities. This allows a completely seamless and automated experience around sample planning, processing, and data alignment. The filtration technology is based on a unique filter press using TFF, direct injection into most common analyzers is supported, and the volume of just 2–4 mL of total loss per sample allows frequent sampling even for smaller scale benchtop systems. Together with Lucullus®, Numera® allows the loop around sample analytics and process feedback (control) to be closed in an out-of-the-box fashion.

The aforementioned Securecell biotech offerings Numera® and Lucullus® are proven process-changers for biopharma drug development. They optimize typical lab operations by automating workflows and harmonizing the layer above the individual devices. Implementing these innovations, Securecell has now achieved another benchmark in its efficiency mission and is excited to introduce the next generation of lab productivity: IntegraOne.

Numera®
Moving HPLC close to the process with Numera®, a modular autosampling and sample processing system. Bioreactors connected with online HPLC analytics.

IntegraOne—The first and only fully automated solution for bioprocess development and small-scale production

IntegraOne is about a range of innovative products that are being launched to establish a fully integrated, end-to-end bioprocessing platform. IntegraOne will automate manual, repetitive and error-prone work of highly skilled laboratory staff while achieving full data integrity and traceability. Thereby, it will improve your R&D and small-scale productivity and accelerate time-to-market.

IntegraOne covers all relevant process steps, upstream to downstream, and provides all necessary analytical tools to quantify metabolites, and their products, and to record their key attributes with the utmost confidence. It is a total solution for true end-to-end functionality.

The IntegraOne 830 system consists of eight three-liter bioreactors, which sit in the Multifunctional Reactor Base (MFR). The Opera Module 1 in the center acts as the MFR control station and aligns the functionalities of four bioreactors.

The system’s low-volume sampling capabilities are made possible by the Sephara probe. Its silicon membrane allows for the collection of low-volume filtrate samples from each bioreactor. The samples are then routed to the Crunchy Sampler where they are preserved in ice water and protected from evaporation. Each sample is sealed and assigned to a QR-Code autonomously.

For continuous processing via perfusion, the filtrate is routed to temperature-controlled “harvest bags” where its raw products are collected and await redirection to downstream processing.

Content from harvest bags is periodically pumped to the Amphora station for weighing and then sent to the downstream devices for processing.

Amphora scales are also used in unison with the pump configuration of the Opera Module 2, ensuring consumption of all feed solutions. Base and antifoam are controlled and balanced. Subsequently, each reactor’s feed flasks are automatically monitored and replenished from their corresponding media refill bags stored in the refrigeration units.

All air and gas flows are managed by the mass flow controllers in the Opera Module 3 and linked to the system’s pH and dissolved oxygen sensors.

Glucose-concentration can be measured and controlled with the MetaMaster.

Numera® draws samples from the bioreactors and transfers them to the routing module where samples can then be diluted and filtered before they are passed on to the analytical devices, or to be stored in the autosampler for later analysis.

Lastly, the Opera Module 0 is home to Lucullus®, the software conductor of the IntegraOne orchestra. Lucullus® initiates and visualizes all processing cues from planning and preparation through execution and evaluation. Its programming allows each lab to operate a smooth end-to-end process, streamlining every unit for groundbreaking efficiency.

In comparison to traditional setups, IntegraOne provides the highest quality data, generated with a fraction of today’s labor efforts.

The precious cargo of each bio lab solution is the product, and IntegraOne reinvents how to cultivate, sample, analyze and harvest biomass. Its scalability features will revolutionize industrial lab environments like no system before, and it will lead to the future of decentralized bioprocessing and cell therapy.

 

For more details, please contact Securecell at contact@securecell.ch.