PHILADELPHIA, June 14, 2023 /PRNewswire/ — 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 leadership and SMEs were 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.
This 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.
With end-to-end innovation planned for the facility, Genentech’s leadership managed a strong team of supporting players under a one-team approach, challenged to push the boundaries of execution. Set for kick-off in January 2020, the project was faced with obstacles posed by the COVID-19 pandemic early on. However, the Valspec team was quick to pivot and adapt to a “local but remote” approach and mitigate roadblocks through creative solutions to maintain momentum and achieve critical dates.
“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 Valspec’s West Coast Director of Life Sciences, Cory Bowman, who was responsible for the project’s timely and on-budget execution. “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.”
Valspec was awarded the Commissioning and Qualification scope for CSC based on a longstanding partnership with Genentech and a successful track record executing large CAPEX projects. Valspec’s expertise with the project’s specified computer system and agile, innovative approach helped Genentech create a highly integrated facility embodying the principles sought by Pharma 4.0™.
“The Valspec team was honored to be part of this project and commends Genentech for pushing the boundaries of facility design, build, and operation. We look forward to continuing our partnership with the Oceanside biologics manufacturing facility set to be operational in 2025.”
About Valspec
Valspec, headquartered in Royersford, PA, since 1999, is a global provider of computer system validation and system life cycle services, including the testing, commissioning and qualification of manufacturing automation and IT systems. A proven history in plant automation and engineering services has allowed the company to branch out and be highly effective in meeting various project and resource needs for their customers. For additional information about the company, please visit valspec.net.
Contact:
Amy Lowery
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