1st US-Approved Gene Therapy Manufacturing Facility
Genesis worked with Spark Therapeutics to enhance and refine their headquarters. This included the creation of offices, laboratories, and cGMP manufacturing suites that rigorously met international regulatory standards. The project, guided by efficient project management approaches, resulted in the swift design and construction of the facility. This seamless execution aimed to maintain Spark Therapeutics’ operational momentum during the process.
Genesis contributed its expertise through comprehensive Engineering, Procurement, and Construction Management (EPCM) services, ensuring a cohesive approach from initial design to project completion. The central focus was the revitalization of Spark’s hub, transforming it into a contemporary space equipped with modern amenities. The reimagined headquarters now includes not only offices but also specialized laboratory areas, setting the stage for innovative scientific work.
Genesis developed cGMP manufacturing suites, prioritizing efficiency and adherence to rigorous regulatory standards, e.g., the FDA, EMA, and PIC/S.
Integral to the project’s success were advanced project management methodologies. The adoption of Lean Integrated Project Delivery minimized wastage of time, resources, and materials. Building Information Modeling (BIM) provided a detailed virtual representation of the facility, aiding in meticulous planning, design, and construction. Early engagement of contractors through a collaborative design-assist approach addressed potential challenges proactively, facilitating the construction phase.
Impressively, the facility’s conception, design, and construction were accomplished within an expedited eight-month timeframe. The accelerated timeline aimed to ensure minimal disruption to Spark Therapeutics’ ongoing operations.
The project’s design approach encompassed both immediate and future perspectives. While addressing Spark’s present needs, it also aligned with the company’s short-term commercial objectives. Moreover, a forward-looking perspective was integrated into the design, accounting for Spark’s growth aspirations. The facility’s visionary design enables easy scalability and expansion for future manufacturing endeavors.