MSD Animal Health

Execution Strategy

DIALOG Fitzroy adopted a staged execution strategy to align with MSD’s evolving corporate requirements and facilitate fast-tracked delivery of early works. Initial engagement in 2017 focused on concept development and early procurement of long-lead items. Building construction commenced in parallel with design in late 2017. In late 2018, the project was paused to accommodate a major strategic realignment across MSD’s global operations—applying human health GMP standards to animal health manufacturing. Following a comprehensive rewrite of the User Requirement Specifications in 2019 and a Front-End Engineering Design (FEED) phase in 2020, the project restarted with a redesigned scope. A dedicated local engineering team of up to 15 professionals coordinated model reviews, HAZOPs, and GMP workshops with MSD, ensuring compliance and operability. Construction and system installation progressed throughout 2021 and 2022, with offshore fabrication of process skids used to manage cost and reduce site congestion. Mechanical completion of individual systems was achieved progressively between February and May 2023.

Key Objectives

• Replace ageing unclassified formulation spaces with a fully compliant Grade C facility

• Enable accurate and repeatable adjuvant and diluent formulation under GMP conditions

• Eliminate manual handling risks associated with solid NaOH via automated drum lifting

• Integrate automated control and monitoring across clean utilities and process systems

• Achieve seamless operational integration with MSD’s adjacent vaccine production facility

• Support future production capacity and regulatory audits with a validated facility

The B25 Adjuvant Preparation Facility was successfully commissioned and handed over for GMP production qualification in early 2024. All process and building services systems were thoroughly commissioned, including HVAC balancing, airflow verification, downflow booth smoke testing, and glovebox isolator validation. Automation systems underwent full loop testing and field calibration, ensuring integrated control across process and utility systems. Despite the challenges of global supply chain disruptions, pandemic-era restrictions, and significant design growth, the facility was delivered to the required quality standard and regulatory expectation. The project demonstrated the value of collaborative governance, agile engineering response, and early contractor involvement in delivering high-complexity, high-compliance infrastructure within a live manufacturing environment. B25 now plays a central role in MSD’s vaccine manufacturing strategy, enhancing both product integrity and operator safety while meeting stringent GMP requirements.

The project also demonstrated the effectiveness of the NZS 3916 contract model in managing complex, high-compliance infrastructure delivery. Its emphasis on transparency, collaboration, and fair valuation allowed both parties to navigate evolving project requirements and unforeseen challenges without conflict. Weekly governance meetings, open-book variation processes, and joint decision-making ensured that issues were resolved early and constructively. This approach fostered trust, supported agile project management, and ultimately contributed to the successful delivery of a GMP-compliant facility aligned with MSD’s global standards.