During the technology transfer process, test batches are produced and used to demonstrate that the transferred production process will yield an end result that is precisely what is expected by the vaccine sponsor.
Multiple layers of qualification protocols are built into the technology transfer process. These are essential to ensuring the products produced in the Biologics Manufacturing Centre will be safe for human use.
Experts at the NRC are currently preparing the new Biologics Manufacturing Centre to produce its first product—a subunit COVID-19 vaccine developed by Novavax, Inc.
Teams from the NRC and Novavax have been working together since March 2021 on the technology transfer for the Novavax COVID-19 vaccine. While that seems like a really long time, it is actually happening at an accelerated pace, especially as the teams are preparing to produce a new vaccine, in a new facility.
In fact, the technology transfer process began in parallel with construction of the Biologics Manufacturing Centre. With extensive experience in vaccine development, including technology transfer, and housed right next door on the NRC's Royalmount site, the NRC's biomanufacturing experts from the Human Health Therapeutics Research Centre were perfectly positioned to take on the first phase of the technology transfer for production of the Novavax COVID-19 vaccine at the Biologics Manufacturing Centre. This enabled the NRC to start working on the tech transfer before the new facility was ready to use for this purpose.
The NRC has now completed technology transfer batches for the Novavax vaccine at smaller scale, which confirmed that the exact process to produce the vaccine can be transferred successfully to the Biologics Manufacturing Centre. The next step in the process will be to scale up the production process and produce technology transfer batches at larger scale. This phase of the technology transfer will happen inside the new facility once the commissioning, qualification and validation process has been completed and all necessary materials have been received, tested and released. The processes are happening in parallel due to the unique circumstances of the COVID-19 pandemic.
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.