IDBS Polar Control: Drug development’s recipe book for efficient parameter and process lifecycle management

Developing processes and gaining process understanding are essential for successful process development. However, relying on legacy tools and non-digital practices results in fragmented process knowledge, and inefficient and complex development cycles, increasing manufacturing risks.

IDBS Polar Control directly addresses these critical inefficiencies – enhancing parameter management and ensuring accurate process documentation, which paves the way for effective and efficient process development, process characterization and tech transfer.

Features

• **Comprehensive process management: **Maintain consistency throughout the entire process—from setting parameters to extracting valuable insights from results. Track and classify process parameters and quality attributes, and determine specifications and limits at a granular parameter level, to monitor their evolution of processes over time and promote informed process control strategies.
• **Streamlined scientific workflows: **Seamlessly integrate key process data into scientific execution with real-time alerts to minimize errors and reduce deviations. Improve documentation and traceability to ensure teams follow consistent processes, reducing the time, resources and need for repetitive experiments.
• **Facilitated technology transfer: **Monitor process variability in process development and process characterization studies to build the development process needed for yielding high-quality product. Build product and process knowledge together, to establish operating process control requirements and create replicable, reliable processes for transfer between teams.
• **Continuous learning: **Keep a comprehensive history of every process parameter to gather knowledge as processes evolve. Link process and product data to establish essential connections between process versions and execution experiments, allowing you to seamlessly view which parameters impacted product quality. This enables continuous process optimization and informed decision-making.
• **Enhanced quality and compliance: **Maintain accurate and organized data to simplify adherence to data integrity and regulatory standards, and to monitor product quality with greater ease. Centralize all data on a single platform, – building trustworthy data and facilitating easier access and management for report creation and regulatory submissions.