This new production complex is designed to have the capacity to generate between 40 million and 50 million doses of seasonal influenza vaccines, incorporating both its corporate offices and research and development activities.
The novel facility encompasses various crucial components, including a commercial-scale manufacturing plant tailored to produce biological products, specifically focusing on manufacturing a quadrivalent seasonal influenza vaccine in a structured manner to achieve a daily batch output. This manufacturing facility encompasses vital supportive functions, such as plant growth areas (greenhouse/production), upstream processing, downstream purification, manufacturing services, buffer preparation, warehousing, utilities, and waste management. Importantly, all manufacturing processes adhere to the current Good Manufacturing Practice (cGMP) guidelines, as well as the biological confinement regulations stipulated by Health Canada, the US Food and Drug Administration (FDA), the European Commission (EC), and the World Health Organization (WHO) Guidelines.
Furthermore, the new pilot plant encompasses upstream and downstream sectors, while dedicated Quality Control laboratories ensure rigorous product assessment. The facility also houses Research and Innovation (R&I) laboratories, encompassing Analytical Development (AD) and Process Development (PD) sections, driving ongoing advancements. Administrative and management offices and associated ancillary and communal amenities are integral to the facility's infrastructure. A state-of-the-art greenhouse mechanical fertigation system is also be incorporated to support the overall operations.