Bioprocess data landscape

  • 10th October, 2013

Welcome to Simplyfeye Blog!

On this blog Simplyfeye team would be posting information regarding our products/solutions and our views on process data management and process troubleshooting in general. Simplyfeye develops products and solutions for biopharma industry for process engineers and scientists to efficiently troubleshoot process issues and continuously improve processes.

Figure below shows various data, information, knowledge repositories and how the content flows (generated and consumed) from one to another during the normal execution of a commercial manufacturing process life cycle of a product batch. The information is maintained in systems owned by various functional groups like process development, engineering, quality control, quality assurance and manufacturing.

Currently this information is managed by various electronic systems (as shown in blue ovals in figure below) like:

  • ERP (Enterprise Resource Planning)
  • BMS (Building Management System)
  • MES (Manufacturing Execution System)
  • LMS (Learning Management System)
  • LIMS (Laboratory Information Management System)
  • QMS (Quality Management System)

The "core activity" (as shown below in yellow region) of process development, technology transfer and biomanufacturing operations still don't have any integrated system. The process troubleshooting and process improvement activity still lacks a formal data system that caters to the process analysis needs. This blog and Simplyfeye product and solutions are primarily targeted towards providing insights into this space for efficient data management, monitoring of processes and effective development/manufacturing of biopharmaceuticals.