Clinical Plant Start-up and Technology Transfer

Situation, Goals & Business Drivers

A leading biotech manufacturer acquired a clinical plant to meet three key business drivers:

  • Enable the “go fast” methodology for process development and reduce the average timeline from 22 months to under 12 months.
  • Expand clinical capacity so no project waited more than 2 months for a production slot.
  • Allow the expansion of company pipeline for new molecular entities.

Actions Taken

Corporate developed the overall project goals to align with corporate goals which included reduced project budget, timeline and start up team. A multi-dimensional start up team was created and was held accountable to meet project objectives and define the timing of first production run.

Results Achieved

Project met all project milestones, budget and workforce constraints. Plant delivered the company’s first ever 100% successful clinical run while attaining one of the highest product yields enabling the expansion of clinical trials.