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.
Figure 1. Service Chase in Hemosols Meadowpine Facility
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.
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.
Figure 2. Architectural Rendition of Hemosols Meadowpine Facility
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.
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.
Figure 3. 28-Month Project Timeline
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.