Alexion, Purification Facility

About this project

The new building is designed as a standalone facility independent of the existing manufacturing building with fallow area for future development. The single use design results in a flexible facility, suitable for multiple product introduction, facilitating a fast track project with minimum time to construct and commission. The concept and basic design phases were delivered to a very aggressive schedule of 14 week, including submission of planning, EIS, fire and DAC to the local authorities. This was achieved by close co-operation of the DPS and client representatives, an intensive technology transfer period in the USA and rapid mobilisation of a high quality engineering team in DPS. The following major elements formed the scope of the project

Purification train

• Single Use Pooling and Clarification
• Single Use pH Adjustment with concentrates
• Hydrophobic Interaction Chromatography 1
• Single Use Precipitation and Viral Inactivation
• Cation Exchange Chromatography
• Single Use Nanofiltration, Membrane Chromatography and Ultrafiltration
• Hydrophobic Interaction Chromatography 2

Support

• Buffer Preparation (Single Use and Stainless Steel)
• Single Use Bulk Dispensing
• Equipment Preparation and CIP
• Reverse Osmosis Water and Water For Injection

Building

• Proprietary Grade D cleanrooms
• Personnel changing rooms
• GMP Gowning rooms
• Building control room
• Plant rooms
• Future fallow area for 2nd purification suite

Achievements

• Cutting edge single use design
• Designed with low utility and energy usages
• Closed process design allowing Grade D cleanrooms to be used
• Flexible facility
• Aggressive schedule
• Future expansion space
• Planning, Fire Cert and DAC