A leading biotech manufacturer acquired a large biotech manufacturing plant nearing construction completion. Plans for the acquired plant included manufacturing startup and technology transfer of a leading commercial bio-oncology therapeutic antibody for Regulatory approval within two years.

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.

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