Lucullus®
Comprehensive Software Solution for Bioprocess Digitalization
Lucullus®, as an intelligent software suite, enables automation and digitalization across diverse bioprocessing environments, integrating workflow elements into a single intelligent suite on a digital platform. The overarching bioprocess software solutions promote industry 4.0 standards, ensuring data integrity and full process transparency.
The Lucullus® core software covers general SCADA functionalities that have been extended with unique pre- and post-process features supporting operators across the entire bioprocessing workflow. The functionality can be modularly extended with process planning, sample management, and material management, as well as comon software interfacing capabilities.
- Parallel process monitoring
Comparison of real-time and historical data - Basic Process control
Starting and stoping processes on selected bioreactors and adapt process setpoints and parameters during the process - Advanced Process control
Automation and real-time calculation - Data evaluation
3rd party analysis software integration (MATLAB, Python, DataHowLab, ...) - Process planning
Including equipment, procedures, parameters, sampling events and materials - Media and warehouse management
Electronic recipes and guided media preparation - Multi-user access
User, group, and role management - Meets regulatory compliance
Regarding 21CRF Part 11 - Oversee Data
Supervising your processes with easy access to all relevant information on site and remote.
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Comprehensive solution
A single bioprocess software for monitoring, controlling, and managing data, planning samples, and handling raw materials -
Overarching integration
A wide range of control units, PAT sensors, analyzers and more are supported -
Increased productivity
Structured and automated workflows throughout the entire process chain, from planning to evaluation -
Scalable architecture
Customizable implementation from single facilities to the whole enterprise -
Efficient collaboration
Simplified data and information-transfer between laboratories, departments and sites -
Data Integrity
Secured, structured and traceable stored data from various sources -
Unlimited access
Exchange of harmonized data with the existing software landscape / 3rd party software, through OPC-UA and RESTAPI interfaces
Lucullus® License Types
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Basic
Data Acquisition, Process Monitoring
In modern bioprocessing, collecting data from diverse sources is essential to gain a comprehensive understanding and valuable insights into the process. With Lucullus®, this is realized through seamless connectivity and vendors agnostic integration of various equipment.
The data is centrally stored in a structured and harmonized manner serving as a hub for consolidating the aggregated data. These foundations enable the subsequent application of process knowledge in advanced control strategies for automation.
Benefits
- Gain Overview
Be on top of your running processes with centralized real-time monitoring. - Oversee Data
Supervise your processes with easy access to all relevant information on site and remote. - Compare Processes
Evaluate performance with comparison of running and historical processes of different scales. - Get Notified
Receive SMS and / or e-mail notifications on alarms and process events.
Information Management
In biomanufacturing, multiple stakeholders play critical roles, including lab technicians, engineers, data scientists, and managers. Each user has distinct responsibilities and requires access to specifi c tools and information.
Lucullus® was purposefully developed to support to the unique needs of each user, offering manageable access and a harmonized interface. It ensures that all users have the necessary tools and information at their disposal, facilitating seamless collaboration and optimizing workflow efficiency.
Features
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User Management
Define users, groups and permissions via Lucullus® or existing LDAP -
Remote Access
Secure data access from everywhere in the network -
Audit Trail
Recording of all the user interactions during the process and projects -
Information Transfer
Seamless and harmonized data exchange between laboratories, departments and sites
Evaluation & Reporting
Lucullus® collects data from various sources across the entire bioprocess environment, storing them securely in one central location.
All process information is accessible for automated visualization, evaluation and batch reporting. Lucullus® provides efficient database search options, analysis tools, data export features, and automated paperless documentation to support your needs.
Features
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Efficient filtering options to easy access all the historical process data
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Customized visualization of data in graphs or tables
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Advanced realtime processes evaluation with integrated tools (e.g., smoothing, regression, integration)
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Programmable sequential evaluation for standardized process analysis and reporting
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Data export options for selected data sets and graphs in various formats
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Automatically generated reports with customized templates
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Data integration with 3rd parts software such as databases and mathematical, statistical, and machine-learning tools
Control
Process Control & Automation
Lucullus® collects data from various sources across the entire bioprocess environment, storing them securely in one central location.
All process information is accessible for automated visualization, evaluation and batch reporting. Lucullus® provides efficient database search options, analysis tools, data export features, and automated paperless documentation to support your needs.
Features
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Efficient filtering options to easy access all the historical process data
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Customized visualization of data in graphs or tables
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Advanced real-time processes evaluation with integrated tools (e.g., smoothing, regression, integration)
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Programmable sequential evaluation for standardized process analysis and reporting
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Data export options for selected data sets and graphs in various formats
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Automatically generated reports with customized templates
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Data integration with 3rd parts software such as databases and mathematical, statistical, and machine-learning tools
Basic Control
The basic process control functionalities of Lucullus® include effortless process loading, initiation, and termination, alongside the ability to modify setpoints and parameters. Additionally, it provides a comprehensive visualization of process states, alarms, and events, offering a holistic overview.
Centralized, uniform interface for overarching process control:
- Start and stop processes on selected bioreactors
- Adapt process setpoints and parameters during the process
- Apply predefined control strategies to single processes or process groups
- Configure customized notifications for alarms, process conditions, or events
Advanced Control
The basic process control functionalities of Lucullus® include effortless process loading, initiation, and termination, alongside the ability to modify setpoints and parameters. Additionally, it provides a comprehensive visualization of process states, alarms, and events, offering a holistic overview.
Centralized, uniform interface for overarching process control:
- Start and stop processes on selected bioreactors
- Adapt process setpoints and parameters during the process
- Apply predefined control strategies to single processes or process groups
- Configure customized notifications for alarms, process conditions, or events
Extended
Process Planning
The Lucullus® Planning tool empowers users to design future bioprocesses using a guided workflow. Operators can pre-define and schedule reactors and associated equipment, specify attributes, and select control stepchains and alarms. This structured planning approach for future processes or process groups ensures smooth process starts and seamless knowledge transfer, facilitating efficient operations and effective process implementation.
1. Define process groups
2. Select devices and define attributes
3. Assign operations and media
4. Schedule processes and sampling events
Sample Management
Lucullus® revolutionizes sample management and the associated data assignment to respective processes. While reactor sampling and sample processing are still performed manually, the samples are now stored in tubes labeled with barcodes. Lucullus® automatically creates unique barcodes for each sample, which are subsequently scanned at the off-line analyzer.
By generating a unique barcode ID, Lucullus® automatically imports the sample results upon completion of the analysis and assigns them to the corresponding process and process time, streamlining data integration and ensuring accurate tracking of sample information.
Benefits
- Manage samples efficiently by applying sampling strategies, defining methods and preparing tubes with barcode labels
- Be reminded during process execution to take a sample at predefined sampling intervals
- Record exact timing of sampling to align on-line and off-line data
- Retrieve data automatically from at-line analyzers
- Automate sampling and sample processing even further with the Numera® PAT system
- Use sample data for advanced process control
Automated Sampling With Numera® System
The combination of the automated sampling system, Numera®, and the Process Information Management System, Lucullus®, enables the orchestration of the whole workflow covering sampling, measurement, process monitoring and control. Read more here
Material Management & Media Preparation
Lucullus® offers digital assistance for media lot preparation and seamless integration of raw material information. Lucullus® facilitates a streamlined workflow from media planning to media optimization through guided media preparation using electronic protocols. Lucullus® also enables efficient warehousing and ensuring traceability of components throughout the process, enhancing overall efficiency and quality control.
Benefits
- Check and monitor the availability and the usage of compounds from storage
- Reduce human errors for material handling due to guided workflows and barcode technology
- Manage your media recipes in a structured library
- Automatically record data in your media kitchen with integrated devices (e.g., pH meter, scales, etc.)
- Link media lots and compounds to experiments
- Use the information gained during experiments for media optimization, comparison, calculation and reporting
- Identify and monitor critical material attributes
Optional: 21 CFR Part 11 Compliancy
Lucullus® is designed to fulfill the requirements for electronic records and electronic signatures for GMP applications. It is compliant with the FDA 21CFR Part 11 guideline.
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Access Security |
The Access Security includes features such as the use of a unique combination of user ID and password, customizable password security settings, comprehensive logging of access security actions in an audit trail, and extensive user management capabilities for roles and groups. |
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Electronic Signature |
Lucullus® enforces the authorization of defined interactions by a user with the appropriate authorization. Confirmation of changes is requested with pop-up windows. The following information is stored in the audit trail: reason, timestamp, and printed username. |
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Audit Trail |
Lucullus® provides a continuous audit trail that is protected against deactivation and tampering. It tracks the user interactions and all events during a process. A second audit trail on the database level logs all changes in system configuration. |
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Archiving and Retrieval |
The Lucullus® interface is designed to prevent process deletion and raw data modification to ensure data integrity. A robust data integrity checking mechanism prevents the deletion of resources associated with active processes and serves as an additional layer of protection to ensure data consistency and reliability. |
“Lucullus® automates and digitalizes Amyris’ bioprocess environment with more than 100 integrated reactors from small to large scale. Lucullus® has truly transformed our operations and opened new possibilities.”
- Timothy Leaf
Scientist Fermentation Lab Operations at Amyris Inc
"Lucullus® helps us contextualize and automatically aggregate experimental on-, at- offline & meta-data into one database. It thus forms a core element of our digital workflow."
- Dr. Michael Thiele
Assoc Dir, Head of Bio MSAT-USP at Teva Biotech GmbH
"Lucullus allows us to compare the data of running processes with data from historic processes to evaluate process performance in real-time and to establish our complex fermentation processes during upscaling"
- Dr. Miriam Grosse
Head of Fermentation at Helmoltz Center for Infection Research
“We chose Lucullus® which flexibly integrates an unmatched 100 laboratory devices allowing the complete digitalization of our GMP manufacturing environment.”
- Navjyot Waghmare
Automation Expert at IDT Biologika
The integration of Securecell's Lucullus® process information management system with DataHowLab, an advanced data analysis tool, will enable users to merge streamlined data collection and organization with sophisticated machine learning and modeling capabilities. This collaborative interaction between the two tools, leveraging the expertise of both companies, represents a significant stride towards achieving comprehensive digitization. It signifies a shift from mere monitoring and control to knowledge-driven digital solutions, aligning with the objective of Bioprocessing 4.0.
Insights
September 10, 2024
