Valspec Named Key Partner in Genentech’s FOYA in Pharma 4.0 Category

Valspec, a global provider of system validation and lifecycle services, was named a key partner in Genentech’s Clinical Supply Center (CSC) project, which was recently recognized with the Facility of the Year (FOYA) 2023 Pharma 4.0 Category Winner Award by ISPE.

The CSC is a proof-of-concept facility in South San Francisco that uses advanced manufacturing technologies and employs an agile, modular design to enable on-demand delivery of Genentech’s medicinal pipeline to clinical trials patients, according to Genentech. As a supply partner and key participant, Valspec owned the commissioning and qualification scope for the plant’s computerized systems—a critical role that would allow the plant to be released for clinical-scale manufacturing.

Valspec was involved early in the project lifecycle, starting with the Automation Quality Project Plan (aQPP). Valspec developed the testing matrix based on user requirements and collaborated with the System Owners, Automation, Equipment C&Q, and QA project teams to gain approval. This alignment served as the roadmap for the project as the teams progressed through Detailed Design, Design Review/Design Qualification, and C&Q Testing activities.

According to the company, the project set a precedent for Pharma 4.0 with its innovative design and advanced integration of digitalization and automation. The plant’s automation stack is fully integrated from the plant floor through enterprise-level systems and combined with single-use equipment to create an extremely flexible environment that allows for rapid tech transfer. Beyond its novel plant technologies, CSC was Genentech’s first large capital project executed with a paperless validation platform.

“This project has raised the bar in life sciences and will serve as a template for other companies seeking to achieve the benefits of Pharma 4.0,” said Cory Bowman, Valspec’s west coast director of Life Sciences. “Incorporating digital solutions and integration into biopharma environments opens the door to endless possibilities that will ensure every patient has access to innovative treatments and medicines.”