- Montréal, Quebec
Recently, terms like developing, producing, manufacturing and even simply making a vaccine have all been used somewhat interchangeably. However, there is a distinct and very important difference between developing a vaccine and producing it. While the vaccine developer and its producer may have different responsibilities, they share a common goal—making a safe and effective vaccine.
Many pharmaceutical companies have the capacity to both develop and produce large volumes of their own vaccine. Other biotechnology companies develop vaccines but don't have in-house capacity to produce, or choose to supplement their capacity, so they contract a GMP-compliant facility.
Once it receives a drug establishment licence, the Biologics Manufacturing Centre will be a GMP-compliant production facility. Vaccines and other biologics will be produced in the facility according to the specifications outlined by the vaccine's developer, who is essentially a client, but is usually called a vaccine sponsor. In industry terms, the Biologics Manufacturing Centre is considered a contract manufacturing organization (CMO).
Teams at the Biologics Manufacturing Centre are currently preparing for the production of a COVID-19 vaccine, which was developed by the facility's first vaccine sponsor, Novavax, Inc.
The vaccine sponsor is responsible for ensuring its vaccine receives the required approvals in Canada. For example, in February 2022, Novavax received Health Canada authorization of their COVID-19 vaccine in adults 18 years of age and older.
The difference seems obvious. Why is it so complicated?
Although there is an important distinction between vaccine development and its final production, the dividing line is sometimes a bit blurry. For example, part of a vaccine's development involves perfecting the production process in a lab (lab scale) and scaling it up to produce small quantities of the vaccine for pre-clinical testing. This means the vaccine developer may do some small-scale vaccine production, while process development and production teams in a specific manufacturing facility will establish the exact production process for full manufacturing. Are you finding this all a bit unclear? Don't worry, you aren't alone.
Unlike most manufacturing processes, there is really no margin for variation between doses of a vaccine. Each dose in each batch must be exactly the same. To ensure this absolute precision, a massive amount of work goes into perfecting the vaccine's production process. This takes place throughout the vaccine's development phase, but also while preparing for its production at commercial scale.
Developing the production process in the Biologics Manufacturing Centre
The vaccine sponsor, Novavax, has been working with the production team at the Biologics Manufacturing Centre since March 2021, to ensure the process to produce the Novavax COVID-19 vaccine will work at full scale with the exact equipment inside the Biologics Manufacturing Centre. The teams have completed technology transfer batches at smaller scale (also called pilot batches) and are now working on scaling up the production process and producing technology transfer batches at full scale.
When the vaccine sponsor and the vaccine production team at the Biologics Manufacturing Centre are confident that everything is in place to execute the full-scale vaccine production process exactly as required, they will begin the production of the engineering runs. These test batches confirm that the production process will produce the expected results at full commercial scale. Several engineering runs may be required to ensure the results are reproducible and reliable.
Once the vaccine sponsor is satisfied that the production process has consistently produced the high quality product in multiple engineering runs at full scale, then production of process performance qualification batches can begin. The Biologics Manufacturing Centre team will provide data for the vaccine sponsor to demonstrate that these batches are consistent with the sponsor's approved vaccine, and that the production process is consistent, reproducible and GMP-compliant. The vaccine sponsor is responsible for submitting the results of these batches, and all the supporting documentation, to Health Canada for approval.
Once Health Canada approves the process performance qualification batches, the focus will shift to commercial production at the Biologics Manufacturing Centre.
Clear responsibilities and a common goal
When a biotechnology company contracts a biomanufacturing facility to produce its vaccine, there is a clear distinction between vaccine development and vaccine production, with expertise required from both sides. Then, the key to successfully manufacturing a vaccine is strong collaboration between the vaccine sponsor and vaccine production facility, with both teams intensely focused on their common goal of consistently making the highest quality vaccine.
Read other stories in this series to learn more.
Update: Following an inspection in July, Health Canada issued a drug establishment licence for the Biologics Manufacturing Centre on August 5, 2022.
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