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Continuous monitoring – at any time and from anywhere

The more complex the biotechnology process is, the more difficult it is to predict how the process will run. Data volumes are also growing, driven on the one hand by the number of clones being analyzed and on the other by the process parameters being monitored and controlled. Mobile monitoring of critical process parameters and an intelligent information management system offer an efficient solution.

The economic success of biopharmaceutical products depends heavily on the development cycle of the corresponding production processes. Acceleration of the development processes offers enormous savings potential but places high demands on the efficiency and reliability of the methods deployed.

DASGIP AG, based in Jülich, Germany, provides pioneering technologies to enable rapid, permanent and location-wide utilization of bioprocessing data.

Biotechnology processes are characterized in particular by materials that are often costly and by run times that can take up to several weeks. In addition, the process behavior is not always predictable, leading to the occurrence of key events at unexpected points in time.

In order to optimize the processes, the parameters are varied and the thresholds of the system ascertained. Parallel processing offers a time- and cost-saving instrument, particularly in this environment. Because, unlike production, R&D areas are not organized to work in shifts, continuous monitoring of the processes cannot be adequately ensured.

In light of this, mobile technologies create innovative opportunities for monitoring critical process parameters at any time and from any location and if required, allow direct intervention in the processes.

Another challenge for laboratories when it comes to process development is the growing amounts of data. Developing new medications with complex interdependencies not only requires the monitoring of numerous parameters, but they must also be recorded in detail and systematically analyzed. The parameters that are captured when cultivating bacterial, animal and human cells in a bioreactor include temperature, pH value, dissolved oxygen and the actual values of key actuators such as the pumps, stirrers and gassing components. Furthermore, data such as live cell density and nutrient or metabolite concentrations are ascertained using external analyzers.

Permanent overview of continuous processes
One way to access bioprocesses at any time and anywhere is the DASGIP Remote Control system. The web browser-based application enables access from a PC, Mac or laptop computer without having to install software. Users can not only monitor the current processes online, but directly intervene in order to change reference values or deactivate pumps, for example. The alarm option triggers immediate warnings, which can even be sent via e-mail or text message, when critical deviations occur. DASGIP Remote Control thus gives the user complete control of the bioprocesses from any networked location in the world.

As with all other user intervention activities, remote changes are also logged in the event archive. The integrated access rights management and mandatory authentication control user access in accordance with the company-specific guidelines for security.

The well-established DASGIP Remote Control system has been enhanced with the innovative iApp. The DASGIP iApp is the world’s first application for monitoring and controlling parallel biotechnology cultivation processes with the iPhone, iPod Touch and iPad. The DASGIP iApp allows users to monitor and control all relevant process values online in up to 16 parallel reactors at different locations around the world.

The DASGIP iApp takes advantage of the innovative features of these mobile devices such as multitouch capability or position-dependent visualization (Figure 1). The universal DASGIP application automatically adapts to the device on which it is installed. This provides hitherto unsurpassed simplicity in the operation and layout of the application.

Users can enjoy a wide range of display options using different windows, zoom and rotation functions, all of which can be intuitively managed in typical Apple fashion. In the trend chart, for instance, users can glance at the reference and process values as well as the control profile. They can also use the graphic timeline to browse around between historical and real-time process variable data in a stepless manner. An overview lets users track the current values of critical process parameters. Any warning or alarm thresholds that are exceeded are highlighted.

The user device, iPhone or iPad, can be connected to the DASGIP system via Wi-Fi or GSM (Global System for Mobile Communications, the world's most popular mobile telephone standard). Data security is ensured by utilizing VPN (virtual private network) connectivity (Figure 2.) As with all official applications for the iPhone and iPad, the DASGIP iApp can be purchased through Apple's iTunes Store. This also ensures a user-friendly distribution process for new versions of the application.

All research data in a central database
DASGIP Remote Control is enabled via an OPC link. This open network standard is used to connect the individual devices to the central control software. The OPC connection can be used to integrate not only external control platforms to the bioreactor system, but also other equipment such as sampling and analysis devices, provided the bioreactor system has an OPC interface.

The DASGIP control software collects the incoming data and visualizes and stores it together with the process data in a central database. Using the Data Mining tool, the process data can be merged with process-relevant information such as feeding strategy, cell and media composition, live cell counts or product yields. The information in these databases can be stored and retrieved based on user-defined keywords. Integration in long-term archive and process control systems enables the uniform archiving of process and analysis data from different systems. Scientists can access this research data from any company location.

Users thus benefit from technologies that make it possible to utilize the research data in a holistic fashion, from the bioreactor system to the individual laboratory. The research data is seamlessly integrated into the information infrastructure of the company and simplifies targeted access to the knowledge. That gives the user an edge not only in knowledge but also in time.

Parallel processing
In combination with the tried-and-tested parallel processing, the intelligent information and integration management system offers enormous potential to save time and money during the process development phase.

The DASGIP system can operate between 4 and 16 reactors in parallel, with working volumes ranging from 35 ml to 4.5 l. The system offers diverse functions such as monitoring and control of pH, dissolved oxygen, optical density, exhaust gas analysis and determination of redox potential.

Because large volumes of data are generated during parallel processing, as with the Data Mining tool or integration in external long-term archive and process control systems, the intelligent information management adds great value. With the DASGIP Remote Control software, users can access this data in online mode at any time and from anywhere and directly intervene in running processes.

From its inception some 20 years ago, DASGIP has always focused on the parallel planning, execution, monitoring and analysis of bioprocesses using centralized control software, including extended control functions. With the introduction of the iApp, DASGIP is once again certifying its global technology and innovation leadership in the field of parallel cultivation systems for biotechnology processes.

Martin Grolms | DASGIP AG
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