Fill-finish is arguably the most critical step in the overall drug manufacturing process. It comes after upstream bioprocessing — the formation of the active agent by a cell culture or fermentation — and downstream purification.
Fill-Finish is a relatively mature, primarily industrial activity, concentrating on efficient product formulation and packaging. Fill-finish, much more than bioprocessing, involves complex mechanical engineering filling, fluid and solid dispensing, and sealing systems.
In aseptic fill finish a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering (or closing) of a container happens after this step, with the exception of when a drug requires sterile lyophilization.
It is important to note the criticality of these later-stage development processes. More specifically in a fill finish process, innovation quite possibly can be a silent killer. However, in fill- finish even the smallest of mistakes can lead to a production failure and an overall loss with an already expensive product.
This is one of the main reasons why AbbVie CMO aims to use tried-and-true industry processes during our aseptic fill finish solution in our end-to-end drug manufacturing.