Liquid and lyophilized vials - Two Annex I compliant BSL-2 cleanroom suites.

• 6,300 sq. ft sterile GMP manufacturing facility
• Two Annex I compliant BSL-2 cleanroom suites
• Dedicated containment suite
• Up to 50L bulk volume
• Lyophilisation (x2) with gas overlay
• Up to 3,000 vials per batch
• Temperature-controlled quarantine and storage of drug product GMP material management
• Grade A filling environment
• Restricted Access Barrier (RABs) technology
• Two cleanroom suites each with lyophilizer
• Dedicated cleanroom suites for Containment and Conventional drug handling
• Semi-automated filling by peristaltic pump
• Cleanroom camera monitoring
• Temperature controlled cleanrooms
• Adjacent inspection and labelling rooms
Lyophilization
• Tofflon Lyo 5 model with total 5.4m2 shelf space
• Aseptically qualified for 2,3,5,10, 20 and 50ml vials
• Bulk lyophilisation in Lyoguard trays
• Lyophilisation cycle development / optimisation on GMP scale
• Maximum batch size currently up to 3,000 vials
• SafeBridge Category 3 and solvent containment