Strategic Support for Next-Generation CGT Platform

The Ask

The client asked for a review of the development status of equipment and disposables in addition to the projected timeline for the manufacture and readiness of GMP ready systems with the output being a gap analysis and recommended remediations.

The Impact

The client received a gap analysis and an action list, with detailed supporting analysis and recommendations identifying specific remediation necessary to achieve their challenging launch timetable.

DHC’S Approach

First, DHC reviewed the foundational requirements documents (URS, FRS, SRS etc.) for the system design to check for maturity, clarity, and conciseness, as well as any duplication, all by way of ensuring that requirements were testable and traceable/trackable to a verifiable source.
Next, the team studied the project GANTT chart with the client’s PM to thoroughly understand the reported status to promised timelines and management’s future expectations at a sub-system and system level for the program.
With an understanding of the development baseline and the upcoming milestones, our team performed a deep dive into the status of each of the development disciplines with the respective design leaders including an assessment of the maturity of the system design: assessing the existing prototype equipment and consumables as well as the proposed changes for inclusion in the next generation system.
Our review also included a resource assessment to map required effort with the current company resource profile.