ASEPTIC FILL FINISH
ASEPTIC FILL FINISH
AbbVie’s Aseptic Fill Finish Solution
We offer two convenient fill-finish options for parenteral drug products: prefilled syringe and vials. As a leading pharmaceutical partner, we can provide all necessary elements of delivering high-quality parenteral products for clinical and commercial needs.
AbbVie will leverage its know-how and proven quality, regulatory, and operational network to help you achieve your milestones through comprehensive development and manufacturing support for your vial and syringe drug product formulations.
Understanding the Fill Finish Process for Your Drug Product
Fill-finish is the final manufacturing step (and arguably the most critical) in the overall drug manufacturing process. It comes after upstream bioprocessing, otherwise known as the formation of the active agent by a cell culture or fermentation. It also takes place after 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.
Aseptic fill finish is the area where a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering (closing) of a container happens after, with the exception when a drug requires sterile lyophilization. It is a critical part of biopharmaceutical manufacturing.
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, since fill-finish is a critical part of the biopharmaceutical manufacturing process, even the smallest of mistakes can often lead to the ultimate nightmare of production failure which equates to an overall loss with an already expensive product.
This is one of the main reasons why we aim to use tried-and-true industry processes during our aseptic fill finish solution. It also brings to life our core message of “Experience Unrivaled” when dealing with AbbVie’s end to end drug manufacturing process.
