Case Studies

Commercial Plant Start-up & Technology Transfer

See how Enterey helped a leading biotech manufacturer through a plant acquisition that included manufacturing startup and technology transfer of a leading commercial bio-oncology therapeutic antibody that was ready for Regulatory approval within two years.

Clinical Plant Start-up and Technology Transfer

A leading biotech manufacturer acquired a clinical plant and worked with Enterey to meet three key business drivers: enabling "go fast" methodology for process development and to reduce the average timeline from 22 months to under 12 months, expansion of clinical capacity so no project waited more than 2 months for a production slot, and an expansion of company pipeline for new molecular entities.

Quality & Manufacturing Business Process Improvement Program

A major biotech manufacturer was anticipating rapid growth of operations and had plans to move to a significantly larger facility. In order to achieve the scale necessary to operate the new facility the company had to improve existing business processes and eliminate inefficiencies. See how Enterey helped them meet their growth targets.

Headcount Optimization

A major biotech manufacturer called on Enterey to identify headcount targets and required efficiencies at specified run-rate targets to support a 50% reduction in cost per gram by year-end 2009. See how Enterey helped this client improve operations performance without sacrificing business production.

Inspection Readiness for Facility Startup

A leading biotech manufacturer had set timelines to license its new facility and to pass all required inspections – State, FDA, and EMEA Pre-Approval Inspections. See how Enterey helped support 14 departments with project management leading to successful licensing and passing of all inspections.

Biotech Plant Acquisition - Transition & Integration

A leading biotech manufacturer acquired a large biotech manufacturing plant and needed to quickly integrate the site and employees into its operations to address significant demand concerns. Enterey provided project management to meet aggressive deadlines set to ensure the new plant was producing marketable product within the targeted timeframe.

Biotech Plant Acquisition - Transition & Integration

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 seamless manufacture of its newly acquired product as well as four contracted products. See how Enterey helped deliver a smooth transition and meet all key milestones.

Class A Certification

A leading biotech manufacturer expanded their existing business improvement program to attain Class A certification. The program included three key projects; Class A certification, SAP implementation, and Lean initiative. See how the Enterey team helped this client achieve planned and predictable business performance.

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