RBI Vaccine Bulk Drug Manufacturing Renovation
Resilience Biotechnologies Inc.
Resilience Biotechnologies Inc. (RBI), a centre of excellence for contract manufacturing of biologics and vaccines, has undertaken a major internal renovation to construct multiple vaccine bulk drug production lines within the existing GMP manufacturing core. The lines consist of Mammalian Cell Culture (MCC), Upstream Process (USP), Downstream Process (DSP), and formulation equipment and suites designed to manufacture Monoclonal Antibody (mAb) and related therapeutic proteins. This renovation is supported by the Canadian Government under the Industrial Research Assistance Program (IRAP).
The scope of work consists of a major renovation with concurrent demolition / construction work while at the same time maintaining GMP operations within the facility, including critical process services, WFI, HVAC, and the aspectic core of the building. Project work is on-going and includes project management (design phase), design and costing peer review, constructability assessments, project execution strategy, construction plan, scheduling, and construction services.
The scope of construction included early works, equipment demolition, and facilitation of client change control, as well as the following:
- Mechanical and electrical systems, BAS
- Clean utilities (WFI, Clean Steam, CIP)
- Process systems (buffer preparation, buffer hold)
- GMP HVAC systems reconfiguration
- Autoclave and parts washer area renovation and rigging / installation
- Automation (bioprocess equipment integration, IT network, SCADA system, OSI PI)
- Bioprocess equipment rigging / installation
- Commissioning and start-up of all major systems
- Support of client IQ / OQ activities