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Engineering

Drug Substance Manufacturing Facility Design
EPCMV Cell Culture
  • China - Confidential Client
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Project

Description

This was a Greenfield multi-product drug substance facility. The facility was designed with hybrid equipment, developing an optimum mix between single use technology and stainless steel equipment.

The equipment systems included media prep, seed and production bioreactors, harvest, buffer prep and hold, upstream purification, downstream purification, bulk drug formulation and fill, and buffer preparation.

Scope

Of Services
  • Basic, Conceptual and Detailed Design (BD, CD, DD)
  • Automation Engineering – Programming Process Modeling, Conceptual Process Design and Layout
  • Basis of Design Report, Cost and Scheduling Process and Clean Utility Equipment Specification
  • 3D Process Equipment and Sanitary Piping Model
  • Automation Specifications and valve matrices
  • Construction Management Support
  • BioReactors: Design and integration of 50L and 200L Single Use Bioreactors, and 1,000L and 5,000L Stainless Steel Bioreactors. Design included process design through PFD, P&ID, scale up and bioreactor specification, piping integrations, automation (specifications and valve matrices).

Solutions, Results,

and Accomplishments
  • PROJECT Throughput
  • 4 x 5000L Cell Culture
  • COMPLIANCE
  • US FDA, SFDA
  • CAPEX
  • $ 68 Million
  • OVERALL
  • 60,000 Sq. Ft.
  • CLEAN ROOM
  • 18,000 Sq. Ft.
Current Equipment ID# (PFD Rev 1.0) Type Description Capacity Specified Unit Vessel / Bag (F/M/D) Tote / Rack Mag Stirrer (Bag)
BRV-01 Disposable Bioreactor 50 L D N/A Y
BRV-02 Disposable Bioreactor 200 L D N/A Y
BRV-03 SS Bioreactor 1000 L F N/A N
BRV-04 SS Bioreactor 5000 L F N/A N
BRV-05 SS Bioreactor 5000 L F N/A N
RSV-01 Tank-SS Resin Slurry Tank 700 L F N/A N
Deleted Tank-SS Pool Mix Tank (ProA) 3000 L F N/A N
MPV-02 Tank-SS Media Prep Mix Tank 4500 L F N/A N
MPV-01 Tank-SS Media Prep Mix Tank 1500 L F N/A N
MPV-03 Tank-SS Media Prep Mix Tank 300 L F N/A N

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