Contribution to the design of critical aseptic formulation facilities
Securing supplier choices and process interfaces
Quality alignment and cGxP compliance from the early stages
Context and key issues
As part of Novo Nordisk Chartres' ambitious site expansion program, which aims to double production capacity within the next five to six years, agap2 Life Sciences is playing a central role in the AP (Aseptic Production) project. Our teams are supporting the design and development of the equipment necessary for this industrial growth, with a particular focus on facilities dedicated to insulin formulation.
Managing the design definition of weighing isolators, including coordination with supplier ProSys (site visit – Cork, Ireland)
Technical evaluation and participation in the selection of mobile vessel suppliers for future production facilities (Supplier Selection)
Review, analysis, and adjustment of P&IDs and PFDs related to weighing isolators and process interfaces
Providing technical and quality support for engineering decisions, ensuring compliance with cGxP requirements and Group standards
Weighing isolator design finalized, with a supplier ready for manufacturing launch
Securing supplier choices for mobile vessels, reducing supply risks
Alignment of validation and quality documents with international Group requirements
Enhanced integration of formulation requirements from the design and supplier selection phases
Discover other high-stakes assignments where our expertise in engineering, project management, quality, or supply chain has enabled us to turn constraints into concrete results.
