BioMarin, Fed Batch Readiness Project

About this project

Process/support systems

DPS was responsible for the design associated with the upstream fed batch train and implementation of a new downstream protein capture train including chromatography capture and UF/DF.

The project which is an upgrade and expansion of an existing facility utilised single use mixing systems (SUM) for the buffer hold, viral inactivation and column feed and collection steps.

The project included technical transfer of 2 incoming products under an aggressive schedule adjacent to an existing operational facility.

DPS scope included design, equipment and contract procurement for the following:

• Bioreactor vent filter arrangement
• Harvest skid modifications
• Viral inactivation skid modifications
• Chromatography skid
• Effluent handling systems upgrade
• Vendor expediting

Key challenges

• Fast track design implementation schedule.
• Integration with site based project team.
• Delivery of phased design to suit upstream and downstream manufacturing windows of availability.