Wave Life Sciences, Oligonucleotide Production Facility

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).