Aseptic Formulation Suites

[Formulation_1, 2, 3 & 4]: Suite for blending of drug substance and buffers.

Optima 7000 Line

[Filling_1 & 1B]: Commercial vial line: 2 mL - 100 mL vials.

Inova H3-5V Line

[Filling_2 & 2B]: Commercial syringe line: 1 mL - 5 mL pre-filled syringes.

Rota 150 Line

[Filling_3 & 3B]: Clinical vial line: 2 mL - 10 mL vials.

Flexicon FMB210 Line

[Filling_4 & 5]: Clinical vial line: 2 mL - 20 mL vials.

Offloading

[Offload_1]: Optima 7000 offloading suite. [Offload_2a]: Overview of Inova H3-5V and Rota 150 offloading suite. [Offload_2b]: Offload_2b: A view into Inova H3-5V filling from offloading suite. [Offload_2c]: View into Rota 150 filling from offloading suite.

Sterile Filtration

[Filtration_1]: Transfer of drug product and buffer through filters for final filling.

DP Manufacturing Support

[DPSupport_1 & 1B]: GMP Glasswash, autoclaving, oven. [DPSupport_2]: Equipment staging

DP Manufacturing Corridors

[DPCorridor_1]: View of aseptic fill corridor. [DPCorridor_2]: View of formulation suite. [DPCorridor_3]: View of formulation suite. [DPCorridor_4]: View of aseptic filling suites. [DPCorridor_5]: View of GMP glass wash suite.

Inova H3-10 Line

Commercial multi-purpose line: 2 mL - 20 mL syringes, vials and cartridges

Debagging Suite

Ready-to-use (RTU) components are debagged in preparation for filling activities