Genentech
Project Gutenberg & Project Neo-T
Location: Hillsboro, OR
Timeline: 2020–2023
Project Background
Compli supported Genentech’s Project Gutenberg and Project Neo-T by providing Commissioning, Qualification and Validation (CQV) services for a new advanced manufacturing facility dedicated to gene and cell therapies. This greenfield project involved managing and executing CQV activities for utilities, equipment and temperature control units (TCUs), supporting Genentech’s expansion into innovative therapeutic manufacturing.
Approach
The project was executed using ASTM E2500 principles, emphasizing a risk- and science-based approach to C&Q. The team used ValGenesis, a fully digital validation lifecycle management system, which enabled a paperless process and streamlined documentation across stakeholders.
Team Coordination
Working closely with corporate engineering, system owners and facility stakeholders, Compli played a critical coordination role—aligning teams across multiple disciplines to meet project milestones and ensure smooth implementation of the novel validation approach.
Outcome
Genentech selected Compli based on the strength and experience of the project team, particularly the familiarity with advanced validation methodologies and digital CQV platforms. The result was a successful startup that met rigorous industry standards while supporting the future of advanced biologics manufacturing.