The challenges of maintaining a contaminant-free fill-finish environment are numerous and complex, ranging from cleanroom maintenance to equipment sterilization to aseptic lyophilization and stoppering. These challenges grow in complexity as broad-base “blockbuster” drugs are ousted by targeted biologics that must be manufactured in small batches, demanding a high degree of flexibility in the manufacturing environment.
Forward-looking manufacturers are addressing these evolving complexities via a variety of innovative tools and technologies. For example, a growing number of facilities have replaced at least some of their conventional stainless steel fill-finish equipment with single-use instruments composed of disposable polymers. A significant number of manufacturers have also added the technology to aseptically fill syringes to maximize the yield of costly drug substance. And many have augmented their human capital with automated or semi-automated filling processes.
Although all three of these innovations have increased efficiency and flexibility at the fill-finish stage, they also introduce new risks into the process, and remain limited in their applicability. Thus, a manufacturer must carefully consider the cost-benefit tradeoff of adopting any of these novel techniques and tools. The following sections will examine the costs and benefits associated with each of these innovations in greater detail.