IPS was tasked with delivering a new innovative, highly-reconfigurable greenfield drug substance manufacturing facility with essential support functions to provide additional mammalian cell culture fed-batch DS capacity.

The facility design leverages the client’s existing capabilities in Manufacturing of Future (MoF) processing, combined with a proven ability to commercialize innovative concepts. The design incorporated user and business requirements, sustainability, and Digital Technologies 4.0.

The design included the following key concepts:

• Sizing the production bioreactors to match the existing MoF cell culture scale for seed bioreactors and purification capacity.
• Unique engineering solutions for interfaces between single-use to stainless sections of facility.
• Reconfigurable section enables future Intensified Fed Batch (PD-led initiative to develop a new process platform to achieve a higher output).

The client’s vision is to have a facility that is modular, expandable, and allows for phased expansion rapidly without disrupting ongoing operations.

IPS generated a BIM model and execution plan including a complete strategy for the entire project that is used to implement 3D through to 4D, 5D, 6D, and 7D integration by organizing the project information and deliverables, adding the meta data, tagging structure, and CSI UniFormat to align with the project schedule and project control work breakdown structure. Information was pulled from the BIM model and the P6 schedule into Fuzor and Destini to be used as part of the 4D and 5D BIM integration.

The client plans to have this facility’s commissioning and qualification complete by Q2 2024, with regulatory approval by early 2026. To meet this timeline, IPS developed an approach to this fast-tracked project as part of the preconstruction services.

The site plan was developed to allow both incremental facility expansion and to accommodate potential undefined expansion in the future with new facilities.

The facilities were split into four main building and three ancillary buildings:

• Manufacturing building includes all process operations, clean utilities and a second level with a mechanical mezzanine, electrical and VDER rooms, office, a process development lab, and a modular data center.
• Warehouse building adjoining the manufacturing building designed to store just-in-time supply of raw materials and freezer capacity for 3 months storage of DS product.
• Central utility building (CUB) includes all plant utilities, main electrical switchgear, process chilled water system, maintenance shop, office and a modular data center. Process waste tanks are located outside of the CUB and cooling towers will be located on the roof.
• Manufacturing support building includes the cafeteria, offices, QA/QC labs and a mechanical penthouse.
• Rainwater treatment building
• Fire pump house
• Wastewater treatment building