Benefits for the
life sciences sector

Life Sciences is facing the necessity to further lower the costs for production, where on the same side regulations and the need for quality assurance is raising. Xavo Professional Suite supports in streamlining and optimizing production and quality control processes.

 

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FLEXIBILITY

Our Life Sciences customers need to differentiate their offering with new and innovative products meeting exactly the demands and regulations of the target market. This actually leads to a huge variety of different formulas, processes and products which need to be efficiently planned, developed, controlled and executed. Xavo Professional Suite comes with many planning and execution features helping to keep track of complex production plans and flexibly react to unforeseen events or changes of the plan.

HIGHER
EFFICIENCY

In the Life Sciences environment, new products must be efficiently developed, tested, controlled and produced. Xavo Professional Suite helps eliminating inefficiencies in your laboratories and your operations. For example, an optimized production plan can reduce cycle times in laboratory environments by still maintaining the required flexibility, or the raw material inventory can be optimized based on real time material consumption data.

OPTIMIZED WORKFLOWS

Supporting different kind of user groups – like operators or shift supervisors – is key in realizing optimizations. Optimization can only be achieved when all team members exactly know what to do how and when, and the necessary information is provided in real time. Xavo Professional Suite provides configurable workflows, allowing all users to get heir job done in the best possible way. This also supports in meeting the required regulatory compliance level.

IMPROVED TRANSPARENCY

To all companies in the Life Sciences market applies: the broader the product portfolio and the more complex production operations become, the more important it is to exactly know what’s happening and why it happened. Xavo Professional Suite gives you access to all relevant information at all stages of your process – from laboratory processes to process planning and execution, filling and packaging up to production declaration. Those are the tools you need to take decisions on what and how to optimize – from both product and production perspective.


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Research | Cell Biology  

With technology that is available today, cells became a very interesting model for experiments. As a consequence there is in an increasing demand for cells. Today, researchers want to request cells for their screening campaigns delivered in a specific format, quantity and quality at the right point in time. To be able to compare results from cellular screenings, it is essential that the quality of the cells is constant during the screening campaign. It is not unusual, that the cultivation of cells for a screening campaign requires a set of 50+ single activities that need to be executed at the right point in time over several weeks. These days, Cell Biologists have to cultivate cells for multiple screening campaigns in parallel on shared equipment. Xavo Professional Suite helps Cell Biologists to model and to schedule their activities efficiently and guides its users to execute it in time. With Xavo Professional Suite our clients stay on top of things, collaborate with research groups and react to changes in the plan in time to increase the reliability and trust in their cell deliveries.

  • Assisted modeling of cell production activities for various cell types
  • Scheduling of all activities for every order across days and weeks
  • Optimization of equipment usage like freezers, incubators and lab devices
  • Optimization of media and lab consumable stocks
  • Real-time visualization in Gantt-charts
  • Usage of historical data to refine cell growth value and improve schedule of activities
  • Collaborate with requestors like screeners to increase productivity (e.g. reduce cycle times)

Research | screening

A screening campaign usually lasts several weeks where screens are performed at specific dates. For each of these dates, screeners need to ensure that equipment and material is available. There are several types of screens like bio-chemical or cellular assays for target-based or phenotypic campaigns. Today, screening labs need to screen several campaigns in parallel and share the expensive equipment like microscopes. With Xavo Professional Suite the screener can model the flow of material of compounds, proteins, cells, buffers and lab consumables and specify the equipment types for every type of assay. The real-time planning Gantt visualizes the current plan and allows its users to share the expensive equipment and as a result increase the utilization.

  • Model a variety of assay types with configurable workflows
  • Share expensive equipment to increase utilization
  • View current status and plan of material, equipment and personnel in real-time Gantt-charts
  • Receive notifications about current and upcoming issues
  • Integrate lab equipment and automation devices
  • Collaborate with compound management and cell biology labs to increase productivity (e.g. reduce cycle times)
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Research | Compound Management

Compound Management is an essential service at the heart of drug discovery, having a large number of sources, clients and collaboration partners. Strategies need to be in place to ensure a proper orchestration of all activities from sample reception to proper storage and fulfilment of sample requests.
Cycle time and quality are key success factors in drug discovery when it comes to providing compound samples. Also, with limited space, equipment and personnel, efficient usage of what is available, is essential.

  • Out of the box support of a variety of labware formats, volumes and concentrations from single tube, dilution series to replicated plates
  • Possibility to specify capability of liquid handlers
  • Schedule execution based on optimization goals like
  • minimize turn-around-time
  • minimize compound usage
  • minimize number of intermediate plates
  • minimize tip usage
  • Visualize compound management activities in real-time Gantt-charts
  • Support of various equipment and system integrations like liquid handlers, automated stores, scanners, auditors and labellers
  • Intuitive user guidance for every lab activity
  • Collaborate with requestors like screeners to increase productivity (e.g. reduce cycle times)

Production | Packaging

After the API has been produced it needs to be formulated so that it can be stored in a steady state. Based on the demand, the formulated API is filled into the container, typically vials or syringes, labeled for the specific end market and packed so that it can be shipped. With Xavo Professional Suite, its users can adapt to the changing demand of shrinking batch sizes and execution just in time. With its configurable workflows, the dependencies between material, equipment and personnel can be modeled and scheduled based on their availability. Proven algorithms help to react faster and better to unforeseen changes and increase the quality and reliability of the formulation and packaging process. It is a ISA-95 compliant MES system that provides planning, scheduling and execution support in a single technology stack. It combines demand planning and real-time monitoring functionality in Gantt-chart views and it integrates with available ERP, PCS and QMS systems.

  • Increase productivity by minimizing change-over time
  • Schedule activities by respecting material, equipment and personnel availability
  • Support for quality operations and gateways
  • Plan, monitor and document maintenance operations
  • React faster to changing demands and batch sizes

 

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Production | API

The production of biological active pharmaceutical ingredients (bio APIs) is more complex and take longer than the production of synthetic APIs. Over weeks, multiple groups are working together to cultivate cells from an inoculum, ferment them and purify the material to produce the bio API. Over the whole process quality needs to be monitored and reacted in case of deviations. Media and buffers need to be produced from ingredients in time. The production of bio APIs highly depends on the availability of personnel, material and equipment at the right point in time. Xavo Professional Suite is an ISA-95 compliant MES system that integrates Planning and Execution in a single technology stack. With its Gantt-chart views and planning algorithm it assists the planners and users in their day-to-day operations. It integrates with available ERP, PCS and QMS.

  • Longtime to real-time planning and scheduling from end to end
  • Monitoring of cell growth and algorithm supported adaption of the production forecast for dependent activities like purification
  • Gantt-chart views and algorithm support for planners
  • User guidance for the daily operations of factory workers (digital SOP)
  • eSignature support for paperless production
  • Dedicated platform enables collaboration between production teams
  • Proven algorithms help to react faster and better to unforeseen changes

API Development | Pilot Plant

For every project, a biological pilot plan receives instructions from the technical transfer team, how to setup and parameterize the upstream (USP) and downstream (DSP) process, so that the produced biological entity can be used in clinical trials. The cultivation of cells in the USP usually lasts several weeks and utilizes multiple fermenter sizes. Once the cultivation has been completed, the purification is usually completed within a few days. The duration of USP depends on the effective growth rate of the cells and may vary some days. This causes issues in DSP that only takes a few days. If at the end of USP, the amount of material is above the original expectation, more DSP strains need to be established so purify the new biological entity as fast as possible. With Xavo Professional Suite multiple projects can be scheduled and executed in parallel. It allows USP and DSP teams to plan, schedule and monitor their activities and it notifies them in case of changes.  Overall it increases the collaboration and productivity of the biological pilot plant.

  • Model projects for USP and DSP teams
  • Schedule availability of equipment, material and personnel
  • Enable collaboration between USP and DSP teams
  • Reduce risk of timing conflicts
  • Automatically scheduling of media and buffer production
  • Long-term to short-term planning capabilities in Gantt-chart views
  • Consolidated project management Gantt-chart view
  • Support of skill management
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Contact our Experts

The quickest way to check out how Xavo Professional Suite can help you is to ask one of our experts. We are happy to answer all your questions about our product.

Your Contact

Thomas Frech

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