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    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 21 CRF Part 11
    • Oversee Data
      Supervising your processes with easy access to all relevant information on site and remote.

    • 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 an Overview
      Be on top of your running processes with centralized real-time monitoring.
    • Oversee the Data
      Supervise your processes with easy access to all relevant information on-site and remotely.
    • Compare Processes
      Evaluate performance by comparing running and historical processes at different scales.
    • Get Notified
      Receive SMS and/or e-mail notifications of 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

    • 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

    • Efficient filtering options to easy access all the historical process data

    • Customized visualization of data in graphs or tables

    • Advanced real-time process evaluation with integrated tools (e.g., smoothing, regression, integration)

    • Programmable sequential evaluation for standardized process analysis and reporting
    • Data export options for selected data sets and graphs in various formats
    • Automatically generated reports using customized templates
    • Data integration with 3rd parts software such as databases and mathematical, statistical, and machine-learning tools

    Control

    Process Control & Automation

    Process control plays a central role in bioprocess development and production. With Lucullus®, you can implement both basic and advanced control mechanisms to ensure the precise execution of process commands across all connected reactor systems. Lucullus® seamlessly collects data from standalone devices using its powerful data integration capabilities and provides comprehensive real-time information for control purposes.

    Process step chains dictate the chronological sequence of events, regardless of whether the control actions are automated or performed manually by operators. With its integrated control sequences and event-based decisions, Lucullus® enables the implementation and execution of process designs without any restrictions.
     
    Advantages

    • Facilitates the parallel start of multiple processes with variable recipes

    • Increases efficiency and robustness through prepared process strategies and monitoring

    • Ensures product quality by controlling critical process parameters and critical quality attributes

    • Improves batch-to-batch consistency, reducing the risk of human error and faulty processes

    • Saves operator time through unattended process execution and full automation

    • Easy technology transfer from R&D to production

    Basic Control

    The basic process control functionalities of Lucullus® include effortless process loading, initiation, and termination, alongside the ability to modify setpoints and parameters. It also provides a comprehensive, real-time visualization of process states, alarms, and events, thus ensuring a complete operational picture.

    Centralized, uniform interface for overarching process control:

    • Start and stop processes on selected bioreactors
    • Adjust 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

    Advanced process control enables the development of automated process control strategies. This includes a wide range of actions based on events and schedules, such as triggering supplementary feeding, parameter changes, phase changes, and a variety of other options. The system offers pre-built modules for calculations, user interactions, feed profiles, and other functions that simplify process programming with an intuitive approach.

    Process control strategies for higher-level control and process automation:

    • Step chain programming with alternative branches and parallel steps
    • Defined event- and time-based user interactions
    • Integrated alarms and operator notifications (e.g., email and SMS alarms)
    • Ready-to-use software programming modules (e.g., calculators, interactive user consoles, profilers, exponential and linear ramp functions, PID controllers, etc.)
    • Advanced, script-based process programming
    • Integrated utilities/tools to go beyond predefined modules and program advanced calculations for process control

     

    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® significantly improves sample management and the efficiency of data assignment to relevant 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, thereby streamlining data integration and ensuring accurate tracking of sample information.
     
    Benefits
    • Manages samples efficiently by applying sampling strategies, defining methods, and preparing tubes with barcode labels
    • Issues reminders during process execution to take a sample at predefined sampling intervals
    • Records the exact timing of sampling in order to align on-line and off-line data
    • Retrieves data automatically from at-line analyzers
    • Can automate sampling and sample processing even further with the Numera® PAT system
    • Uses 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 ensures traceability of components throughout the process, enhancing overall efficiency and quality control.


    Benefits
    • Check and monitor the availability and usage of compounds from the storage
    • Reduce human errors during 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 21 CFR Part 11 guideline.

    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.

     

    		  

    Electronic Signature

    		 Lucullus® enforces the authorization of defined interactions by authorized users. Confirmation of changes is requested via pop-up windows. The following information is stored in the audit trail: reason, timestamp, and printed username.

     

    		  

    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 at the database level logs all changes made in system configuration.

     

    		  

    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

    From Data to Wisdom with Lucullus® and DataHow

    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

    The industry-leading, vendor-agnostic
     platform for digital bioprocessing

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