Just in Time. An Approach for a cGMP Fill-Finish Facility

Designing and constructing a technically complex yet efficient, fully integrated fill-finish facility is no small task. The timeframe can be long, the costs can be high, and the stakes with numerous stakeholders involved, can be even higher. But this case study of one biotherapeutic company’s new fill-finish facility in Hillsboro, Oregon, provides practical insights and steps for success for “just in time” delivery of a fully operational and costeffective ground-up manufacturing facility in a shorter timeframe than typically witnessed by industry standards. The end goal of this project was to bring a licensed fill and finish facility online to ensure reliable supply of product to patients through innovative design, sustainable technologies, and effective use of capital. By all accounts, the “just in time” process and mindset facilitated this, laying the groundwork for a shift in the way the industry approaches and completes complex projects.