Modular Construction: Innovation, Flexibility, and Adaptibility by Design - Modular construction can reduce build times and mitigate risk without sacrificing time-to-market. - BioPharm International

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Modular Construction: Innovation, Flexibility, and Adaptibility by Design
Modular construction can reduce build times and mitigate risk without sacrificing time-to-market.


BioPharm International



Figure 1. Service Chase in Hemosols Meadowpine Facility
Risk is part of biopharmaceutical development. Planning for commercialization typically starts after completion of phase 1 trials. If you wait until the end of phase 3 to build a manufacturing facility, years of profitable sales will be lost. If you build a factory too early, you risk the possibility that the factory will be idle while waiting for product approval. After all, in today's regulatory and economic climate, the odds of successfully bringing a product from discovery through clinical development to commercial success are less than 1 in 100. Companies cannot be blamed for questioning when, or even if, they should build a new facility to manufacture a product for commercial launch. However, modular design can reduce this risk by reducing construction time and increasing flexibility.

In the summer of 2000, Hemosol decided to build a state-of-the-art manufacturing facility — a carefully planned strategic move to position and accelerate the commercialization of Hemolink, a hemoglobin-based oxygen carrier (HBOC). This endeavour was intended to transition the company from an R&D organization to a fully integrated manufacturing-based company poised to capitalize on the billion-dollar market for oxygen therapeutics.


Figure 2. Architectural Rendition of Hemosols Meadowpine Facility
Outsourcing Hemolink manufacturing was not a viable alternative. Hemolink is a large volume parenteral, requiring a significant capital investment for the large commercial manufacturing process. In addition, at that time it was not possible to find a contract manufacturer who was prepared to handle a human blood-based product.

The choice to proceed with the construction was risky, given that the planned facility completion date was targeted to coincide with the end of pivotal phase 3 clinical trials to permit immediate Biologics Licence Application (BLA) filings in the US, Canada, and the UK. Acutely aware that development plans don't always follow the expected path, Hemosol insisted that flexibility and adaptability be incorporated into the plant design.


Figure 3. 28-Month Project Timeline
When the company experienced unforeseen delays in its clinical program in 2003, this flexibility allowed necessary adjustments to be made to its business plans. Although the corporation downsized and reorganized, we were able to adapt the newly constructed facility — with its many unique and innovative design elements — to accommodate the manufacture of other products. By establishing a contract manufacturing division to serve the biopharmaceutical industry's outsourcing needs, Hemosol is leveraging its expertise and state-of-the-art manufacturing facility to generate revenues and support its own continuing R&D programs. The facility's unique design allowed it to be rapidly retrofitted for contract manufacturing. In June 2004, Hemosol announced a definitive license and strategic alliance agreement with ProMetic Biosciences regarding the Cascade technology, developed jointly by ProMetic and the American Red Cross, used for the separation of valuable therapeutic proteins from human plasma. This represents the first contract manufacturing related activity for the new facility, demonstrating its adaptability and flexibility.

THE MEADOWPINE FACILITY The new 130,000-ft2 building houses corporate offices, laboratories for research and quality control, warehouse space, and the manufacturing plant (Figure 2) on a seven-acre site in Mississauga, Ontario. The facility was specifically designed to meet or exceed the existing standards for the Canadian, US, and European regulatory agencies.


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