Case Study 2 - Front End Design

A new multi-product therapeutic protein contract manufacturing facility incorporating two production suites. The main project objective was to independently validate the design, and to demonstrate the flexibility of the facility to the client, including the capability to manufacture a wide range of different therapeutic protein products (over 80% of those on the market and in development).

Aims & Objectives

  • Design validation
  • Risk reduction
  • Future proofing
  • Independent analysis
  • Capacity prediction

Results

  • Schedule clash = WFI shortage! This is avoidable through careful plainning
  • CIP system over-sized - process uses only 20% of process and 5% of support skid capacity
  • Decontamination system usage < 50%
  • Neutralisation system utilisation >400% caused by concurrent demand from both purification suite
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