4 Questions To Ask Your Fill Finish Partner To Minimize Risk And Maximize Yield

By Ramon Gonzalez, Senior Supervisor of Drug Product Manufacturing

Selecting a fill finish provider that will safely and efficiently prepare your product for the patient is critical for drug developers. Their commitment to mitigating risk and preventing contamination helps ensure patient safety and product quality. An experienced partner will also work to increase product yield and minimize operating costs. The question remains, how do you recognize a partner with these capabilities from the outset of your project?

The answer is to ask a few questions of your own. First, determine what strategies they’ve implemented to minimize yield and increase risk, including leveraging single use systems with peristaltic pumps. Next, determined which technical controls they have implemented for priming, filling, and VHP monitoring. From there, assess their approach to validation, including whether they have implemented a quality-by-design approach. Finally, determine whether you can tour their facilities; with an in-person tour, you can better assess how a vendor has leveraged their previous experience to design streamlined, state-of-the-art manufacturing plants. If you’re ready to learn more about how to select a fill finish provider, download the full article.