On March 31, 2021, Sanofi announced a project of CAD 925 million to construct a new vaccine production building in Toronto, according to a press release by Cision. Paul Hudson, Sanofi's CEO, said, "As a leader in vaccine manufacturing, we are always looking to meet the increasing demand for influenza vaccines. The new project to manufacture FLUZONE High-dose Quadrivalent is key to protecting more seniors against influenza, which is a constant reminder that we've been here before. Moreover, the production of FLUZONE will be an essential resource to help fight against future pandemics."
In addition to producing the FLUZONE vaccine, the new proposed manufacturing facility will boost the growth of Canada's biomanufacturing industry. It will also ensure that the country is prepared to deal with future health crises. However, building a bioproduct manufacturing facility isn't a straightforward process. Investors must ensure their facilities have appropriate designs, pass several regulatory tests, and follow strict building procedures. Below are other key considerations of building biomanufacturing facilities in Toronto.
Define product class
Before the design and construction process of a biomanufacturing facility can begin, investors must define the product they'll be producing. Will the facility be producing vaccines, fragment antibodies, recombinant proteins, or antibody drugs? It's also important to determine whether the products will be microbial cell-derived or extracted from mammal cells. While these questions are key to choosing the facility's design, they are also vital for selecting bioprocessing tech equipment.
Choose reliable supply partners
Once you've defined your product class, consider finding a reliable supply partner. Your supplier should offer customized system designs, especially if you're producing single-use products. These designs are tailored to blend into your workflow process to boost efficiency and quality. However, producing large single-unit systems presents challenges, like packaging, sterility validation, transport integrity, and component supply. With this in mind, ensure your supply partner has a good reputation, effective communication program, and transparent material supply policy. For example, let's say you're manufacturing dental studs, implants, or jawbones. TMS Titanium suggests finding titanium specialists who are ready to work with you and deliver products that will ensure the success of your project. This means your titanium supplier should have a proven track record of supplying high-quality titanium rods, sheets, and blocks.
Know the regulations
Regulatory guidelines and compliance requirements linked to building manufacturing facilities differ from country to country. However, each regulatory body expects bio manufacturers to clearly define if products are for research or pre-clinical purposes, commercial sales, or clinical trials. Doing so makes it easy to determine the appropriate GMP or good manufacturing practice requirements. If manufacturing bioproducts at a commercial scale, find out if they are approved by your country's regulatory board like FDA, the China FDA, or European Medicines Agency. Remember, local biomanufacturing regulations go beyond the global ones. For instance, Japan and Korea have stricter earthquake-proofing measures than anywhere else in the world.
The construction of new biomanufacturing facilities creates a unique opportunity to reevaluate basic designs and utilize new technologies to build efficient structures that meet set regulations. Typically, building or expanding facilities for biomanufacturing can be daunting, but it shouldn't if some factors are considered upfront. These considerations include defining bioproduct class, understanding bioprocessing regulations, capacity, and selecting supply partners.
