Symbiosis Pharmaceutical Services Ltd. | Scion House

• 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