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Commercial Plant StartUp

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Commercial Plant Start-up & Technology Transfer

Situation, Goals & Business Drivers

A global pharmaceutical manufacturer acquired a large biotech site and marketed product from another global pharmaceutical manufacturer. The company needed to integrate the new site and employees into its operations and ensure the company seamlessly continued manufacture of its newly acquired product as well as four contracted products.

Actions Taken

Project plans were created to include completion of the construction phase of the plant, manufacturing startup and transfer of the antibody. Key milestones were set, project teams developed, and communication plans defined. Enterey provided project management support for the lead project manager of the receiving plant reporting into the site leadership team, and for site preparation for regulatory inspections by the state, FDA, and EMEA.

Results Achieved

Construction, plant commissioning, and commercial product manufacturing activities completed on time, leading to successful State, FDA, and EMEA approvals within the initial project timeline.Construction, plant commissioning, and commercial product manufacturing activities completed on time, leading to successful State, FDA, and EMEA approvals within the initial project timeline.