Most commercial combination products will ultimately run on automated lines and rightly so. Automation delivers speed, unit-cost advantages, and tight, repeatable quality control. However, standing up an automated production line can take two to three years and cost millions of dollars in capital and validation investment. Meanwhile, only a fraction of combination products make it from Phase 1 to market approval, with a success rate of roughly 8–23% (~14% on average). Early-phase automation investment is, most often, simply too risky.
In this eBook, Justin Lacombe, Ph.D., Experic’s Chief Scientific Officer, explores how manual assembly often plays a critical, underappreciated role in the development of combination products.