From IND To NDA: The Role Of The Kilo Lab In A Seamless Scaleup

By Robert Hughes, R&D Fellow, and James Springer, R&D Director

Developing and manufacturing a pharmaceutical drug product from clinical to commercial scale is a continuous process of balancing speed and risk. At times, rapid scale up could mean accepting more risk, however, with an experienced manufacturing partner, your team can explore strategies to drive efficient scale up alongside thorough risk mitigation. Often, this process unfolds within a kilo lab, an intermediate space between research and large-scale production where you can assess your manufacturing process and address issues prior to scale-up.

If you want to ensure seamless scaleup for clinical and commercial processes, ideally you will work with a partner that has designed their kilo lab as a scaled down version of their pilot plant, allowing teams to evaluate the workflow with functionally identical equipment to that which will be used during commercial manufacturing. Download the full article to learn more about how a kilo lab can help accommodate the needs of your project.