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Cell Therapy Manufacturing has unique challenges and requires precision handling of complex biological products. Mareana’s Connect™ platform streamlines the integration of complex biological processes with state-of-the-art AI-driven analytics and adaptable data management tools. By enhancing operational accuracy and optimizing data workflows, we enable cell therapy manufacturers to achieve higher standards of quality and compliance, essential in this rapidly evolving pharmaceutical sector.

Challenge

Mareana Connect™

Specialized Manufacturing Needs

Cell therapy manufacturing’s distinct requirements, from handling live cells to ensuring viability, are not adequately addressed by standard software solutions designed for more conventional pharmaceutical processes.

Immediate Yield Improvements

  • Offers data-driven yield enhancement, processing cell therapy data daily across multiple sites to optimize production.
  • Adapts seamlessly to the unique aspects of cell therapy data, ensuring precise handling and analysis.
  • Evolves without the need for changes to data models, even as manufacturing processes adapt.

Operational Overload

Teams within cell therapy manufacturing facilities often face intense pressures to maintain stringent production standards while managing complex operational challenges, leaving scant resources for innovation or process optimization.

Reduced SME Dependence

  • Utilizes advanced AI algorithms to autonomously connect and contextualize data at both the batch and unit-operation levels, reducing the need for SME intervention.
  • Maintains high data quality with built-in functionality, ensuring consistent and reliable outputs without constant oversight.

Manual Data Handling

Heavy reliance on manual, paper-based, and third-party data handling in cell therapy manufacturing not only slows down processes but also increases the likelihood of errors, affecting overall quality and traceability.

AI-Enhanced Data Processing

  • Transforms manual, error-prone processes into structured, reliable, and scalable systems through AI-driven automation.
  • Provides an auditable, efficient method to manage data from diverse sources such as paper batches, certificates of analysis, and equipment records.

Scalability and Adaptation

The rapidly advancing nature of cell therapy technologies demands a platform capable of adapting to current operational needs and scaling to accommodate future growth and innovation.

Facilitated Manufacturing Transitions

  • Designed to support transitions from early-stage external manufacturing to more advanced internal operations, aiding growth at every step.
  • Ensures smooth progression within manufacturing processes, accommodating various stages of scale and complexity.

Insufficient Data Expertise

Cell therapy manufacturers frequently encounter a gap in specialized data management expertise, which is critical for processing and analyzing complex biologics data effectively.

Rapid Platform Deployment

  • Moves your organization to a state-of-the-art SaaS data management and analytics platform within approximately 4 to 6 weeks.
  • Delivers insights in seconds—where it previously took days—using data managed by FAIR standards.
  • Continuously integrates new features from Mareana innovation to stay at the forefront of technology.

Inefficient Data Processes

The absence of structured, scalable data management systems often hampers the efficiency and accuracy of data-driven decisions in cell therapy manufacturing, limiting the ability to leverage information for strategic and operational gains.

Scalability for Expansion

  • Designed to scale with growing data and process needs, supporting everything from small-scale operations to extensive, multi-site operations.
  • Ensures the platform’s capacity grows in line with your organization’s expansion, maintaining efficiency across all operational scales.

Mareana Connect™ Features

Business Outcomes

Genealogy

Offers an intuitive visual mapping of complex manufacturing steps, enabling thorough traceability through forward and backward exploration. Automatically adjusts data models in response to changes in recipes or processes, integrating real-time data for a comprehensive view across all sources.

Improved Batch Traceability

  • Enhances traceability and recall of batches, empowering users to independently navigate and understand complex data without extensive SME dependency.
  • Simplifies the validation and analysis process, enabling just-in-time availability of contextualized data for various needs including RCA and reporting.
  • Acts as a comprehensive knowledge repository for all manufacturing data, streamlining information sharing and technology transfer across sites.

PBR

Automates the processing of data from handwritten paper records into a digital format, streamlining the transition from manual to digital documentation.

Reduced Workload for Employees

  • Significantly reduces the effort required by full-time employees (FTEs) by automating data entry from handwritten paper records.

EBR Lite

Converts paper records to digital entry screens with real-time checks for valid values and dependencies, maintaining flexibility for additional notes and QA approval within hours using a built-in approval workflow.

Rapid Transition to Digital

  • Transition from paper-based systems to digital solutions in weeks.
  • Maintains continuity between traditional and digital record-keeping, allowing some products to remain on paper while others move to electronic batch records (EBR) on the same platform.

AI Copilot for Batch Release

Detects inconsistencies in paper batches, facilitates collaborative review and resolution processes, and offers an intuitive UI for easy training and navigation.

Accelerated Batch Processing

  • Reduce batch release cycle time by several days
  • Reduce time to review batch records to minutes.
  • Eliminates the risk of missing out on review of critical items
  • Enables thorough review of CMO batches in minutes

Data Science Studio

Features purpose-built Python libraries for advanced data analysis and machine learning, tailored to enhance analytical capabilities in manufacturing.

Advanced Analytics Readiness

  • Enables advanced analytics and machine learning directly on the platform, eliminating extensive prep time for data analysis.
  • Provides state-of-the-art analytics capabilities, enhancing organizational insight and operational forecasting.

Statistical Process Control

Provides complete control over the chart’s appearance and functionality, customizes alerts, and integrates with the CAPA system for compliance. Features built-in approval for change control and allows for single-click exploration of Genealogy.

Improved Process Integrity

  • Minimizes the risk of errors from incomplete or unapproved data, ensuring data integrity and compliance.
  • Enables scheduled and on-demand generation of customized reports and alerts, facilitating proactive management of manufacturing processes.
  • Provides full traceability of data sources, transformations, and updates, enhancing control over production data and documentation.

In Process Controls

Integrates IoT data contextualized by batch and process steps, provides user-defined alerts, and employs complex multivariate analysis for operational insights.

Proactive Process Monitoring

  • Facilitates easy exploration and manipulation of time series data for various analyses.
  • Enables complex anomaly detection through multivariate time series analysis, improving the detection of outlying events or trends.
  • Supports the development and implementation of complex multivariate prediction models, enhancing forecasting and strategic planning

Make Confidently, Release Confidently, and Comply Confidently with Mareana Connect™ for Cell Therapy Manufacturing

Schedule a demo now to see how Mareana Connect™ can transform your operations by streamlining data management, enhancing regulatory compliance, and facilitating scalable growth through advanced analytics and AI.

Stay Ahead with
Mareana Connect™

Take your pharmaceutical manufacturing to the digital age with an AI-driven platform that empowers you to Make Confidently, Release Confidently, and Comply Confidently.

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