Facility Upgrade and Expansion
Challenge from the Client
Our client occupies a facility with a footprint of approximately 150,000 SF, across three (3) existing buildings. The campus site spans multiple acres of buildable area. The client has requested that IPS develop a green field facility expansion to support mAbs manufacturing and warehouse operations. In addition to the expansion, the current facility will undergo interior fit-out to accommodate a new vial filling line (Isolator), a new syringe filling line (Isolator), advanced packaging, and 500 L mAbs manufacturing capabilities. The manufacturing facilities will be designed to meet Health Canada, EMA, FDA, PIC/S, NIH, and BMBL requirements for GMP and all other Federal, Provincial, and Local codes. One noteworthy challenge encountered during the implementation of the Isolator was the imperative requirement to adhere to the vertical height limitations of the pre-existing infrastructure.
Our Approach & Solution
To address the challenge of pre-existing infrastructure, IPS engaged in comprehensive discussions with our technical design department to devise and present alternative solutions, ensuring the seamless fulfillment of our client’s specific requirements.
IPS has strategically employed a structured 5-phase approach to project delivery. These phases have been thoughtfully aligned with the client’s growth trajectory, priority objectives, and essential long-lead items.
- Phase 1A: Interior renovations and building expansion for a new Vial Fill Line. Includes a new packaging line and improvements to the Washing and Sterilizing area.
- Phase 1B: Interior renovations and improvements to introduce a new Syringe Fill Line within Building B.
- Phase 1C: Interior renovations to Building C to introduce the mAbs 500 L clinical operations.
- Phase 2: New manufacturing building (approx. 54,000 sq. ft) over three (3) floors to house two (2) Manufacturing trains (2x 2,000 L and ≤ 500 L) used for mammalian cell culture production.
- Phase 3: A new GMP Warehouse will be constructed adjacent to the existing Warehouse in Building A. It will provide ambient storage for ~900 pallets.
The Results
IPS has successfully concluded the conceptual design phase for all five project stages. Notably, Phase 1C, encompassing interior renovation, was given precedence and has been effectively prepared for the bidding process with successful delivery.
