- Montréal, Quebec
As an end-to-end biomanufacturing facility, the Biologics Manufacturing Centre has the capacity to complete the entire vaccine production process – from producing the antigen that causes an immune response, to filling vials and getting them ready for shipping to their final destination.
Although the facility can complete the entire production process, this may not be necessary for every project. For example, a client, usually called a vaccine sponsor, could contract the Biologics Manufacturing Centre to only complete the fill and finish stage of vaccine production. Another vaccine sponsor could contract the facility to complete only certain parts of the process, like producing the antigen or formulating their vaccine.
This flexibility is one of the key advantages the Biologics Manufacturing Centre brings in support of the Canadian biomanufacturing industry.
Why would a vaccine sponsor use more than one production facility?
There are a variety of reasons why a vaccine sponsor might choose to contract out parts of the production process for their vaccine or drug to a production facility.
Although a biopharmaceutical company might have in-house capacity to produce a new drug product, it may need extra fill and finish equipment capacity, especially during the launch of a new product. In this case, they might choose to contract the Biologics Manufacturing Centre, as an approved production facility, to complete the fill and finish stages of their product.
Some vaccines require more than one antigen, either to manage mutations or because it's designed to protect against more than one disease. To more quickly and efficiently produce this type of vaccine, a developer might choose to produce some of the antigens in different production facilities simultaneously, then combine them all during the formulation stage. In this case, the Biologics Manufacturing Centre could be contracted to produce one or more of the antigens, but the formulation and final production stages might take place in a different facility.
Many biopharmaceutical companies have long-standing contracts with specific production facilities that regularly manufacture their vaccines and other products. To produce large amounts of a particular vaccine, or to produce it more quickly, they may choose to supplement these existing agreements by contracting the Biologics Manufacturing Centre to produce part of their vaccine.
It's a common approach for the NRC
It may seem that splitting up the production process is an odd way to do business. But it's aligned with the NRC's collaborative approach for many projects in our research and development facilities.
The NRC assists with hundreds of academic, government and industry-led research and development projects every year. Our role in these projects is usually to help move a client's innovation forward by providing specific expertise and/or access to critical equipment, which may not be available anywhere else in Canada. This means the NRC would not necessarily be involved in all phases of a client's project.
Similarly, the Biologics Manufacturing Centre aims to supplement and fill gaps in the existing Canadian biomanufacturing industry, complementing and supporting academic and privately-owned production facilities, where existing capacity may not otherwise be readily available. Essentially, the Biologics Manufacturing Centre will help with the production process steps that cannot be completed elsewhere in Canada.
Who decides where a vaccine is produced?
As a contract production facility, the Biologics Manufacturing Centre participates in the production of vaccines and other biologics according to the specifications and quality characteristics specified by each client.
The client owns the production process and makes the decision on where to have its vaccine produced. In the case of Novavax, its choice to add the Biologics Manufacturing Centre to its list of trusted production partners across the globe is a testament to the value the new facility brings to the Canadian biomanufacturing industry.
The Biologics Manufacturing Centre team has been working with Novavax since March 2021 on the technology transfer in readiness to produce its COVID-19 vaccine in accordance with its established characteristics.
Read other stories in this series to learn more.
- On April 1, 2023, the not-for-profit corporation, Biologics Manufacturing Centre (BMC) Inc. assumed responsibility for operating the Biologics Manufacturing Centre.
- On August 5, 2022, Health Canada issued a drug establishment licence for the Biologics Manufacturing Centre.
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