Bioprocess Development

Improving compliance and efficiency for the development and production of biologic drugs

The IDBS Bioprocess Execution System (BPES) creates a fully electronic development history record which supports process through the development lifecycle, helping process engineers to develop robust, scalable and transferable bioprocesses. By integrating and optimizing workflows, the system enables more efficient process execution and reporting.

Interactive reporting tools for monitoring process data, efficiency and quality provide the process insight required for a continuous improvement-led approach to biopharmaceutical development and production. This is further enhanced by the ability to drill down into process data and perform "root cause analysis". Robust workflows ensure that Standard Operating Procedures (SOPs) are consistently followed or flagged, capturing data in a consistent way.

The IDBS BPES manages the flexibility required by development users, together with the more fixed nature of Good Manufacturing Practice (GMP) processes, in one integrated environment. Integration of existing data capture tools and disparate data silos allows users to bring enterprise data together in one interface for analysis, searching and submission ready reporting.

Key benefits of the solution include:

• Integrate and optimize bioprocess workflows from development to production
• Remove transcription steps and dramatically reduce errors
• Significantly lower the QA review overhead
• Speed up development, technology transfer and continuous improvement
• Implement a knowledge and data management platform to support ICH Q10 and QbD
• Create process reports in minutes rather than days
• Compare data and perform process intelligence queries to help you learn more about your process
• Use the searching and reporting tools to trace component usage and performance

The IDBS solution offers a flexible and robust environment for the design, execution, capture, analysis, reporting and searching of process information, regardless of file type or location. This allows data to be stored in context and more effectively shared between groups, re-used as a source of corporate knowledge and used to monitor and improve processes. In doing so, it provides support for multiple biopharmaceutical operations: