Downstream processing equipment with the dual trains can be rapidly configured to handle batch sizes entering from harvested cell culture fluid of 200g to 5kg
• Chromatography: ÄKTAProcess and ÄKTAReady, isocratic and gradient
• Single-use virus inactivation (low pH and detergent) and filtration
• Ultrafiltration and diafiltration to perform concentration and buffer exchange
• Bulk drug substance filling using closed system under Grade A supply air.
The downstream area can handle two products in parallel with equipment sized to complete the production in less than 5 days for a typical Mab purified with three chromatography operations.
Bulk Drug Substance can be preserved by rapid or control-rate freezing.
Downstream area with two physically segregated lines sized for nominally 10kg and 1kg of Bulk Drug Substance per batch.
• 2 x Purification rooms (Grade C)
• 2 x Formulation rooms (Grade C)
• Buffer preparation and storage
• Separate column packing room
• Supporting washing room, coldroom, and clean storage.
Separate controlled area for freezing of Bulk Drug Substance (BDS) and storage of equipment.