About This Project

The project included process development lab (synthesis and purification), the clinical manufacturing suite (reagent pre, synthesis, and purification), and the initial planning for the 2nd Phase large-scale cGMP manufacturing capability. The plant utilizes PD scale and small-scale (clinical size) manufacturing equipment to produce the oligonucleotide products.

DPS provided a front-end study and detailed process engineering design. The process scope included the design and specification of the following systems:

• Solvent Waste Collection and Disposal
• Concentrated Aqueous Waste Collection and Disposal
• Acetonitrile storage, distribution and delivery system
• Deblock (dichloroacetic acid / toluene) storage, distribution and delivery system.
• Design of High Purity Water (HPW) generation / distribution system
• Preliminary conceptual design of the Phase 2 tank farm
• Utility distribution and tie-ins

To accommodate the process equipment, the building scope included:

• Interior demolition of an existing building
• Reconfiguration of wall / room layout
• Installation of under slab waste collection piping
• Installation of waste lift stations with containment
• Installation of Phase
• Pipe supports and hangers

The DPS front end study included generation of representative mass balances and waste generation/ collection study.

Our detailed design work involved finalizing:

• Process P&IDs, process piping drawings, and specifications for construction.
• Instrumentation data sheets and specifications for construction
• URS and FRS for the solvent control system; including solvent storage, distribution and delivery control, and waste collection (solvent and concentrated aqueous waste).