Our client embarked in the establishment of the world’s first commercial-scale facility using Single-Use Technology. PDP’s Singaporean office were engaged to provide program and project leadership for this facility start up, encompassing all aspects of operational readiness from supply chain to regulatory approval.
Our mission was ‘to do it differently’, the goal was to deliver a licensed facility in half the time the industry required to deliver a standard biological manufacturing facility. Leading and integrating cross-functional, multi-site teams on such a demanding timeline led to the divergence from the conventional approach, implementing novel and lean project delivery techniques from risk-based decision making to pull techniques that are used to manage the information and material flow between stakeholders.
The project achieved ground breaking results, not only in the technology implemented, but also in the speed of project delivery. In less than 2.5 years, the facility achieved approval from various international regulatory agencies to produce licensed GMP products for world markets.
PDP continues to deliver this service across its international network of offices supporting its clients in providing the same rigour of project execution to operational readiness and New Product Introductions that is traditionally provided at the design and construction phases. Our clients have achieved substantial reductions in schedule and successful regulatory approval in achieving their GMP commercial batches.