Meeting the Changing Demands for the Operations of Sterile-Fill Finish

Fill-finish needs specialized equipment, close coordination, capabilities, and interaction among facilities, equipment, and personnel.

Aseptic fill-finish carries more risk compared to non-sterile processes. Because of this, it needs a greater analysis and specialization. Its operation must be carried out in a sterile environment.

To ensure that the right method is chosen, expert oversight is required.  This is crucial to achieving sterilization without affecting the pharmacokinetic or stability properties of the drug fill finish.

At AbbVie, we deal in aseptic fill-finish and have successfully advanced and distributed drug products for over 130 years, delivering products to more than 175 countries globally. There is no basis for the question as to whether or not we are excellent at what we do. 

The Growing Demand

Due to the technical problems and specialized expertise that are related to the operations of aseptic fill-finish, biopharmaceutical and pharmaceutical companies are actively relying on CDMOs (Contract Development and Manufacturing Operations) to manage this important production phase. Many companies lack sufficient fill-finish operations for sterile products, but even industries that possess these abilities still use CDMOs as a source of backup.

Service providers for sterile fill-finish are responding to the growing demand for technical and capacity expertise. And in many cases, it goes beyond the available capacity. Many sterile fill-finish operators who are employed by CDMOs are adding new technologies to their fill-finish operations.

Strategic Partnerships for the Needs of Equipment

For pharmaceutical companies who are maintaining their fill-finish operations for commercialization, clinical trials, or early development, it is crucial to make excellent decisions when acquiring equipment. The different considerations that are related to sterile fill-finish production – from maintaining the germ-free equipment and cleanroom to making sure that the finished product does not contain contamination and is without degradation to the drug product – make it crucial to install excellent equipment from the early stages of planning.  

A partnership with a supplier of equipment –who possess solid experience with some equipment producers and with customer experience in services such as sterile fill-finish – is an essential asset for any business intending to create hundreds of thousands of used pharmaceutical equipment from equipment from top lyophilizers, sterilizers, and equipment machines, for different packaging types such as prefilled syringes, ampoules, vials, providing cost savings for customers and decreased lead time for installation.

At AbbVie, we handle your product as our own. The nature of your biologic drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable and safe products that patients are ready to use. To learn more about how we can assist you with aseptic fill-finish, feel free to contact us.